November Newsletter

EUROPEAN UNION (EU)

EU guidance on reference laboratories for IVD medical devices | 30 November 2022

EU Commission has published new guidance for candidate reference laboratories in the In vitro diagnostic medical devices field. The document guides laboratories planning to apply in any of the EU Member states. The key topics included are as follows:

  • Conformity assessment procedure for IVDs
  • European Union reference laboratories (EURLs) tasks
  • Selection procedure and designation of EURLs
  • Application procedure to be followed

Notified Bodies under MDR and IVDR | 21 November 2022

The 35th Notified Body, SGS Fimko Ltd, for Regulation (EU) 2017/745 on Medical Devices (MDR), has been added to the NANDO database of the European Commission. There are currently 42 Notified Bodies for Conformity Assessment and Certification under the EU Regulations on Medical Devices, including the seven listed for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

MedTech report on AI Medical technologies | 02 November 2022

The event report from the recently held MedTech Europe event on ‘AI in medical technologies. Speakers from the European Commission, the medical technology sector, patient and healthcare professional representatives, and healthcare insurance discussed the benefits of AI throughout the healthcare systems. They also provided an outlook on an AI regulatory system that works for patients and promotes health innovation.

Medtech Europe Mapping of the pathways for market access to innovative medical procedures | 26 October 2022

A mapping of funding and reimbursement for medical procedures and technologies was completed by MedTech Europe and Med Tech Reimbursement Consulting (MTRC). By screening the situation in 32 European nations between July and October 2022, MTRC examined all of these pathways. The result summarises all the existing payment plans for cutting-edge medical procedures and technologies. The mapping also outlines current, practical efforts to reform healthcare systems and funding and reimbursement systems in some European nations. The report can be accessed here.

IRELAND

Guide to Clinical Investigations in Ireland | 18 November 2022

An overview of the laws governing clinical investigations (CIs) utilising medical devices is given in the guide. The manual also includes instructions on how to apply to the Health Products Regulatory Authority for permission to carry out these CIs in Ireland (HPRA). The Guidance mainly aims at CI sponsors who want to conduct CIs involving medical devices in Ireland, such as manufacturers, academic groups, and clinical research organisations.

GERMANY

Application for Authorisation of a clinical trial of Medical devices | 04 November 2022

The parties involved in conducting, authorising, or monitoring a clinical investigation or performance study (see below) may submit an application for a decision on the authorisation requirement to the higher federal authority in accordance with Section 6(3) MPDG if the regulatory classification of the planned clinical investigation or performance study cannot be clarified.

In accordance with Section 6 (3) MPDG, a non-formal application for a decision on the permission need may be filed to the BfArM. The following can apply for a clinical trial:

  • Sponsors of a performance study or clinical investigation
  • Committees for ethics (treated as competent authorities in this procedure)
  • Representatives of the country

Further details on the authorisation of a clinical trial of a medical device or a performance study of an in vitro diagnostic medical device can be accessed here.

UNITED KINGDOM (UK)

Updated guidance on Clinical Investigation of medical device | 21 November 2022

A clinical investigation may require a UKCA / CE /UKNI marking for medical devices. Medicines and Healthcare products Regulatory Agency has updated the guidance on clinical investigation of medical devices to include a number of filed clinical investigations in the year 2021.

Updated guidance on Clinical Investigation of medical device | 16 November 2022

Before being sold in the United Kingdom, all medical devices, including IVDs, specialised systems, and procedure packs, must be registered with the MHRA (England, Wales and Scotland). To be sold and registered with the MHRA, devices in Great Britain must comply with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), which are in effect there.

Northern Ireland has different registration requirements. Manufacturers, UK Responsible Persons, and Authorised Representatives based in the UK or Northern Ireland are the only locations from which the MHRA will accept the registration of devices (for the Northern Ireland market). The updated guidance can be accessed here.

Guidance on Borderline products | 16 November 2022

Some products, such as those that could be medications, cosmetics, food supplements, biocidal treatments, or personal protective equipment, are difficult to differentiate from medical devices. Until their status is determined, these products are referred to as borderline products.

A product’s eligibility to be considered a medical device is determined by the MHRA, which also informs customers of their eligibility. The MHRA also decides whether a product qualifies as a drug.

The MHRA also considers the device’s risk rating and if it is appropriate for products that are medical devices. A new section, ‘Risk classification of medical devices,’ has been added to the updated guidance.

Risk classification of medical devices

The regulation outlines a system for categorising medical equipment into several risk groups. The level of assessment needed by UK Approved Bodies increases with risk.

“General” medical devices are divided into four classes under Part II of the UK Medical Devices Regulations 2002 as amended (“UK MDR 2002”).

  • Class I – generally regarded as low risk
  • Class IIa – generally regarded as lower medium risk
  • Class IIb – generally regarded as a higher medium risk
  • Class III – generally regarded as high risk

SWITZERLAND

Swissmedic to approve medical devices with FDA approval | 28 November 2022

Swiss Medtech welcomes Parliament’s instructions to the Federal Council to adapt national laws – enabling Switzerland to accept medical devices with FDA approval for the welfare of its population. Until recently, only medical devices with an EU certificate were available to patients and healthcare professionals in Switzerland. It is crucial that the order be carried out quickly and sensibly. Patient safety is important, and waiting is not an option.

Agreement with the United Kingdom on mutual recognition of conformity assessments | 17 November 2022

On November 17, Switzerland and the United Kingdom signed an agreement on the mutual recognition of conformity assessments. This means that in certain sectors, product testing by UK conformity assessment bodies is no longer required for exports from Switzerland to the UK. The agreement will go into effect by February 28, 2023, and will begin to be applied provisionally on January 1, 2023. The Federal Council approved it on November 16.

Issuance of Swiss Free Sale Certificate for medical devices | 11 November 2022

Only goods classified as medical devices under Swiss law and have a certificate of conformity, making them marketable in Switzerland, are eligible for export certifications (Free Sales Certificates, or FSC). From January 1, 2023, Manufacturers and authorised representatives based in Switzerland may request FSC export certificates from Swissmedic by submitting the necessary paperwork and the appropriate order form.

Webinar on in vitro diagnostics regulations | 10 November 2022

Swissmedic hosted an event on the new in vitro diagnostic medical devices to examine current concerns and difficulties from a regulatory perspective on November 3, 2022. The event drew 700 attendees from the diagnostics industry, medical labs, and the healthcare sector. The programme began with a presentation on Swissmedic’s role, emphasising medical devices and the consequences of the EU’s failure to update their Mutual Recognition Agreement (MRA). The event covered a variety of subjects, including advancements in IVD performance studies, stakeholder vigilance obligations, and the needs and responsibilities of healthcare institutions concerning in-house IVDs. Economic operators’ rights and responsibilities, market requirements for gadgets, and registration requirements were also covered.

UNITED STATES OF AMERICA (USA)

Updated FDA guidance on Voluntary eSTAR Program | 15 November 2022

The eSTAR is an interactive PDF form that guides applicants through preparing a comprehensive medical device submission. This form includes the following:

  • Automation (for example, form construction and autofill) (for example, form construction and autofill)
  • Content and structure that is complementary to CDRH internal review templates
  • Combining various resources (for example, guidances and databases)
  • Guided construction for every section of the submission
  • Automatic verification

FDA issued an updated guidance on eSTAR on 15th November.

FDA guidance on referencing the definition of ‘Device’ | 15 November 2022

Section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(h)) contains a definition of the term “device.” The definition of “device” was changed to subsection (h)(1) and a new definition of “counterfeit device” was codified at subsection (h)(2) of section 201 of the FD&C Act as a result of the Safeguarding Therapeutics Act’s (Pub. L. 116-304) enactment.

FDA is issuing this final guidance to clarify on how it intends to interpret existing references to section 201(h) of the FD&C Act and to reference the definitions of “device” and “counterfeit device” in the future. For the benefit of FDA staff, the industry, and other stakeholders, this guidance is meant to provide clarification on the terms “device” and “counterfeit device,” as well as references to section 201(h) of the FD&C Act, in guidance, regulatory documents, and other communications and documents.

FDA Guidance on Standards and Conformity Assessment Program | 15 November 2022

The Standards and Conformity Assessment Program (S-CAP) seeks to promote patient safety, advance regulatory science, and support a least burdensome regulatory framework. By incorporating knowledge from product development, conformity assessment, and standards communities, S-CAP promotes a collaborative approach to standards development and application. This guidance document contains relevant topics such as:

FDA is also conducting a webinar on the ‘Appropriate Use of Consensus Standards’. Further details and the agenda of the meeting can be accessed here.

BRAZIL

Anvisa publishes an updated list of unregulated medical devices | 30 October 2022

National Health Surveillance Agency – Anvisa has updated its list of unregulated devices. The products that fall under this category need not be regulated under Anvisa. The list is updated regularly.

Guidance on IFU and labelling Requirements for contact lenses | 30 October 2022

The requirements applicable to the labelling and instructions for contact lenses are published in this guidance. All medical products must have an IFU in their packaging except Classes I and II, for which safe use is guaranteed without such instructions. Despite being in risk class II, contact lenses must be provided with IFUs to ensure their safety. To meet the information requirements on labels defined in the Resolution, contact lens packaging to have the following:

  • Instructions for use must include the mode of use, warnings and precautions to be adopted for their use, as well as instructions for cleaning and maintaining contact lenses and their cases;
  • The warning “SALE UNDER MEDICAL PRESCRIPTION” on the labels of contact lenses containing prescription;
  • The warning “USE SUBJECT TO MEDICAL PRESCRIPTION” on the labels of non-prescription contact Lenses.

AUSTRALIA

Post-market review of spinal cord stimulation (SCS) devices | 03 November 2022

The following categories of devices from the Australian Register of Therapeutic Goods (ARTG) are covered by the post-market review:

  • Implantable stimulation leads for the spinal cord
  • Implantable impulse generators for the spinal cord
  • Implantable stimulation leads for the peripheral spinal nerves
  • Implantable stimulation leads for the peripheral spinal nerves

The purpose of the review is to reassess the safety and performance of the devices, with the current real-world evidence that is now available for the intended purposes for which they are to be used.

Updated TGA guidance on consent for non-compliant devices | 23 November 2022

Import, supplying or exporting medical devices that do not meet the Essential Principles for safety and performance is a punishable offence under Criminal Offences under section 41MA and Civil Penalties under section 41MAA of the Therapeutic Goods Act 1989. However, circumstances may prevent compliance of several parts of an Essential Principle for a period of time.

In such cases, sponsors can request consent to import, supply or export such medical devices which do not conform an Essential Principle. The guidance provided contains crucial information such as applying for consent for such devices and the method to provide a submission for TGA notification.

MALAYSIA

Guidance document on Change notification for registered devices | 21 November 2022

The Medical Device Authority (MDA) created this guidance document to aid the healthcare community and the industry in adhering to the Medical Device Act’s (Act 737) regulations and requirements. The Medical Device Act 2012 (Act 737), Medical Device Regulations 2012, Medical Device (Duties and Obligations of Establishments) Regulations 2019, and Medical Device (Advertising) Regulations 2019 should be read in conjunction with this guidance document.

The categories of changes related to registered medical devices are outlined in this guidance document, along with the conditions that must be met to keep importing, exporting, or marketing medical devices.

This document covers all registered medical devices under the Act. It lays out the specific requirements a registration holder should consider when changing or modifying a registered medical device. This document only attempts to cover some conceivable combinations and types of change that might affect a medical device due to the wide range of potential outcomes.

Updated Guidance on labelling of Medical devices | 21 November 2022

Labelling is used to both identify specific medical devices and to communicate safety and performance-related information to patients or users of medical devices. Such details could be found in the use instructions, on the packaging, on the device itself or on a leaflet with patient information.

Harmonised standards for labelling would benefit the manufacturer, the user, the patient, and the regulatory authorities significantly. It is less expensive to achieve regulatory compliance and gives patients early access to new technologies and treatments when jurisdictional differences are eliminated or reduced.

MDA’s guide on the labelling of medical devices is meant to instruct manufacturers and authorised representatives on what should be included on medical device labels.

Draft Guidance on Custom-made devices | 09 November 2022

MDA has issued a draft guidance document on Custom-made medical devices. Custom-made medical devices are meant to address unique user needs when commercially available products or complementary therapies fall short of fulfilling those needs. This draft document is intended to guide the specifications of medical devices made to order that qualify for exemption under the Medical Device (Exemption) Order 2016.

CHINA

NMPA notification on Electronic Medical device registration certification | 01 November 2022

From November 1, 2022, NMPA started issuing electronic medical device registration certificates for Class II and Class III devices. The electronic certificate has the same legal effect as that of paper certificates.

NMPA Announcement on Issuing the Guidelines for QMS inspection | 01 November 2022

To efficiently inspect the quality management system for registration under the medical device registrant system and enhance the inspection quality of the quality management system for medical device registration, in accordance with the Regulations on Supervision and Administration of Medical Devices (State Council Decree No. 739), Provisions for Medical Device Registration and Filing (SAMR Decree No. 47), Provisions for In-vitro Diagnostic Device Registration and Filing (SAMR Decree No. 48), Provisions for Supervision and Administration of Medical Device Manufacturing (SAMR Decree No. 53) and other requirements. NMPA has organized to revise the Guidelines for the Inspection of the Quality Management System for Medical Device Registration

INDIA

Updated list of Medical device testing laboratories under MDR 2017 | 21 November 2022

Central Drugs Standard Control Organisation (CDSCO) has updated its list of medical device testing laboratories under the Medical device Rules,2017. The complete list of laboratories can be accessed here. The list contains the contact details, including address of lab, registration number and the scope of testing.

Updated Guidance on Form MD-41 | 18 November 2022

Central Drugs Standard Control Organisation (CDSCO) has updated user manual on on Form MD-41. The user manual contains step-by-step guidance on the application for the grant of a registration certificate to sell,stock, exhibit or offer for sale or distribution of medical devices.

October Newsletter 2022

EUROPEAN UNION (EU)

Guidance on EU Authorized Representatives | 31 October 2022

Medical Device Coordination Group has updated its guidance on Authorized Representatives under MDR 2017/745 and IVDR 2017/746. Under both MDR and IVDR, it is a requirement for manufacturers based out of the European Union to appoint an Authorized representative. The MDCG 2022-16 document further includes the following topics:

  • Designation and mandate
  • Registration and verification obligation
  • Minimum tasks and responsibilities
  • Liability
  • Change of Authorized representative and termination of the mandate

Guidance on Requirements relating to notified bodies | 27 October 2022

The requirements for notified bodies under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices are discussed in this document’s questions and answers. The topics included in this paper have been determined through joint assessments, and it may occasionally be updated as new issues are found. The document answers the questions relating to major topics such as:

  • Organization and general requirements of Notified bodies
  • Quality management system requirements
  • Resource requirements
  • Process requirements
  • Other requirements for Notified bodies

Notified bodies survey on certification and applications | 26 October 2022

The European commission’s latest survey on certification and application under MDR and IVDR has been released. The survey discloses the following vital information:

  • Total number of valid certificates under MDD and AIMDD- 22,793
  • Total MDR applications 8,120
  • Total MDR certification 1,990
  • Main reasons for MDR certification refusal
  • Time required for MDR certification is approximately 13-18 months
  • Total valid IVDD certificates 1,551
  • IVDR application and certification
  • Main reasons for IVDR certification refusal
  • Time required for IVDR certification is approximately 13-18 months

Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure | 20 October 2022

The scientific opinion reflects the views of independent experts on the clinical evaluation assessment report (CEAR) of the notified body. The advice is provided in the context of the clinical evaluation consultation procedure (CECP), which is an additional element of conformity assessment by notified bodies for specific high-risk devices. This expert opinion is on the Class III implantable device which is resorbable sterile mesh. Although the device is not novel, an expert opinion was issued as there was insufficient data whether the device is safe for use. These devices usually show complications over time.

Position paper on Notified Body Transfer agreement | 05 October 2022

The terms of the transfer agreement of Notified body under EU MDR 2017/745 and IVDR 2017/746 is now released. The agreement contains the responsibilities of incoming and outgoing notified bodies.

Class D measures in the absence of EU Reference Laboratories | 05 October 2022

The scope of this position paper is to provide a framework for the verification process for class D IVD medical devices by Notified Bodies (NB) in the absence of designated EU Reference Laboratories

(EURLs). It includes both the verification during the Technical Documentation review prior to certification and of manufactured products post-certification. This position paper reviews possible solutions and implementation measures, however, it is entirely up to a NB to decide what / which methods and solutions are used, if they would like to progress Class D applications in the absence of EURLs.

Position paper on Cybersecurity | 05 October 2022

The increasing number of connected medical devices and ongoing digitisation in healthcare bring new market opportunities for manufacturers and, more importantly, improvements in patient care. The position paper contains Team NB’s recommendations to improve cyber security.

Position paper on Off-label use of medical devices | 05 October 2022

Off-label use is cited in the Medical Device Regulation (MDR) in Annex XIV Part B in the context of manufacturers’ responsibility to proactively identify misuse or off-label use of their devices through PMCF activities, however, neither “off-label use” nor “misuse” are defined in the MDR. This position paper defines “Off-label use” of a medical device as a device used outside of the approved instructions for use including indications. Specifically, off-label use of a device outside the approved indications could include the use of a device.

  • Outside specified populations such as paediatrics;
  • For a different stage or severity of the disease
  • For a similar (not identical) clinical condition
  • Being introduced to the body through alternative routes

Position paper on Submission of Technical Documentation | 05 October 2022

To create a common perspective on the requirements of technical documentation submissions from manufacturers, members of Team NB reviewed the best practise guidance documents that each Team NB notified body member had submitted. They then prepared this best practise guidance document.

The requirements of the Medical Devices Regulation [MDR] (EU) 2017/745, which are in-depth explained in Annexes II and III of Regulation (EU) 2017/745, are linked with this technical documentation submission advice. The document describes the contents of device and description, information supplied by the manufacturer, general safety and performance requirements, risk management and others.

CZECH REPUBLIC

Guidance on Custom-made devices | 05 October 2022

The Department of Medical Devices informs about the publication of the Czech version of MDCG 2021-3 – Questions and answers to custom-made medical devices.

IRELAND

Public consultation on proposed fees | 04 October 2022

Regarding the annual review and proposed fees for 2023, the HPRA is looking for feedback. Consultation will begin on October 4, 2022. The consultation period will end on October 29, 2022. All interested parties are encouraged to respond to the consultation, which is viewable on Consultations webpage. Response documents will be issued providing a basic overview of the comments received and the changes made to the proposals as a result.

UNITED KINGDOM (UK)

Implementation of the Future Regulations | 25 October 2022

According to the government statement, the upcoming Medical Device Regulations will significantly alter the existing framework. The government is committed to making sure that its deployment is done in a way that enhances system preparedness and reduces the chance that UK patients may experience supply disruptions. To have the new regulations in effect by July 2024, we are introducing a 12-month extension to the implementation of the future medical device regulations.

The acceptance of CE-marked products on the British market is set to stop on June 30, 2023, according to the current Medical Device Regulations 2002 (UK MDR 2002). This has now changed. The transitional measures outlined in the government response indicate an expansion of the acceptance of CE-marked medical devices sold on the British market, which is anticipated to be reflected in the revised UK MDR 2002.

After July 1st 2023, manufacturers will still be permitted to sell CE-marked products in Great Britain. The interim measures will be in effect starting in July 2024 for devices with the CE and UKCA markings that are sold in the United Kingdom.

Software and AI as a Medical Device Change Programme – Roadmap | 17 October 2022

Software, including artificial intelligence (AI), is crucial to the social and health care sectors. Numerous of these items are governed as medical devices in the UK. In order to guarantee that the regulatory requirements for software and AI are clear and that patients are safeguarded, the MHRA announced the Software and AI as a Medical Device Change Program last year. The Government’s answer to the consultation on the potential future regulation of medical devices in the United Kingdom outlines broader reforms for medical devices as a whole, which this programme builds upon. Additional details on each work package of the Change Programme, including deliverables to satisfy each group of broad objectives, are provided below. Also, additional details on how the wide Change Programme will be implemented are also provided.

  • Software and artificial intelligence (AI) medical device requirements ensure that these devices are acceptably safe and work as intended, protecting patients and the general public.
  • The demands placed on manufacturers are obvious, supported by both explanatory instructions and streamlined procedures that apply to software, and strengthened by the resources needed to prove compliance, such as the designation of standards.

By collaborating with important partners like NHS England and the National Institute for Health and Care Excellence (NICE), we can coordinate domestically, eliminate duplication, and integrate requirements to provide a joined-up solution for digital health in the UK. Through the International Medical Device Regulators Forum (IMDRF), we will collaborate with other regulators globally to strengthen global convergence and consensus on software and AI products.

Registration guide on MORE portal registration | 14 October 2022

Medical device adverse incidents which occur in the UK must be reported to the MHRA. Post-market vigilance reports are currently submitted by the MORE system or by emailing a Manufacturer Incident Report (MIR) form to the MHRA.

The Manufacturer’s On-line Reporting Environment (MORE) portal registration process via MORE and managing organisation setup are both covered in the paper. Each organisation must have an initial lead user (also known as a “Organisation Lead”) whose registration must be approved by the MHRA. The MHRA will only execute registration requests if the initial user is already registered on the existing legacy MORE system or if supporting paperwork has been provided for individuals who don’t have an account yet.

MHRA Consultation to improve medicines and medical devices’ safety | 13 October 2022

To increase the safety of medications and medical devices, the MHRA is reevaluating how it engages with healthcare practitioners. This consultation closes at 11:45PM 18 January 2023. We want to make sure that healthcare professionals are getting practical knowledge and advice on how to handle medications and medical equipment safely that they can implement into their daily work practises and utilise to give patients prompt assistance.

Guidance for manufacturers on vigilance | 06 October 2022

MHRA has released an updated guidance for manufacturers on vigilance. Modifications to the incident reporting process:

The Manufacturer Incident Report (MIR) form’s XML output, sent to [email protected], or the MORE system are the two ways that manufacturers must submit post-market vigilance reports to the MHRA. This will alter as of November 21, 2022. The new MORE portal or our own Application Programming Interface (API) for direct reporting from your internal systems are the only ways to report adverse occurrences for devices to the MHRA.

SWITZERLAND

Swissmedic update on CHREP audits | 25 October 2022

Foreign medical device manufacturers who want to sell their products in Switzerland must appoint a Swiss authorised agent (CH-REP). The CH-REP is jointly and severally liable for the devices with the manufacturer in all interactions with Swissmedic, cantonal authorities, and patients.

In order to monitor how Swiss approved representatives were putting the regulations into practise on the market, Swissmedic conducted focused, methodical inspections of them in the first half of 2022. A randomly selected sample of 20 Swiss authorised representatives who had registered with Swissmedic nationwide was inspected by Swissmedic between March and May 2022. For the purpose of obtaining a broad picture of the market environment, information was gathered, including details on their operating models. The three official Swiss languages as well as English were used throughout the inspections.

UNITED STATES OF AMERICA (USA)

FDA guidance on developing and responding to deficiencies | 21 October 2022

In compliance with the Least Burdensome Provisions of the Food, Drug, and Cosmetic Act, the latest guidance document assists Food and Drug Administration (FDA) staff in creating a request for more information (FD&C Act). A “deficiency” is the term for such an FDA request for additional information. In order to make the best use of both industry and FDA’s time, this advice also offers suggested formats for FDA personnel to utilise when communicating shortcomings and for industry to use when responding to such requests. For the purpose of facilitating a productive review process, the guidance contains illustrations of well-constructed flaws and industry answers. The guidelines also cover supervisory evaluation, major/minor problems, extra factors, and the order in which deficiencies in FDA deficiency letters should be addressed.

Webinar – Clinical Decision Support Software Final Guidance | 18 October 2022

FDA hosted a webinar for representatives and other interested parties to talk about and ask questions regarding the final guidance on clinical decision support software. The guidance:

  • Explains the scope of the FDA’s regulatory control of clinical decision support (CDS) applications designed for medical practitioners.
  • Explains that software features that match the definition of a medical device, including those that are intended for use by patients or caregivers, continue to be subject to the FDA’s current digital health standards.
  • Examples of CDS functions and software functions for devices that are not hardware.

Further information on the webinar can be accessed here.

CDRH -Total Product Life Cycle Advisory Program Pilot Launch | 11 October 2022

The Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot is being launched, according to an announcement from the FDA’s Center for Devices and Radiological Health (CDRH). TAP is a voluntary programme that aims to reduce the risk of the “medical device valley of death” by giving industry earlier and more frequent interactions with CDRH, more strategic stakeholder input, and proactive, strategic advice from CDRH to encourage more rapid development of high-quality, safe, effective, and innovative medical devices that are crucial to public health.

Position paper on Cybersecurity | 05 October 2022

The increasing number of connected medical devices and ongoing digitisation in healthcare brings new market opportunities for the manufacturer and, more importantly, improvements in patient care. The position paper contains Team NB’s recommendations to improve cyber security.

Guidance on Post market surveillance requirements | 07 October 2022

FDA has issued the latest guidance on post market surveillance requirements under Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Important public health concerns about a device’s effectiveness and safety are addressed with the help of the data gathered as part of a surveillance order. This guidance document is intended to provide guidance to manufacturers of devices subject to Section 522 post-market surveillance orders.

Post-Approval Studies Program | 06 October 2022

When approving a Premarket Approval Application (PMA) or Humanitarian Device Exemption (HDE) application, the FDA may ask for a post-approval study (or studies) to help assure the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of the approved device. Device approval is subject to post-approval investigations. If a sponsor doesn’t follow any post-approval requirements, the FDA may revoke its approval. (Note: A PMA or HDE approval order may require more than one post-approval study for a device.)

The guidance contains the following information:

  • Post-Approval Studies (PAS) Database
  • Obtaining PMA Approval Letters, PAS Protocols, or PAS Final Reports
  • Contact Information

Medical Device User Fee Amendments | 05 October 2022

FDA has released an updated list of fees applicable for different available application types under FDA. The list contains the updated fees for standard applications and fees applicable for small businesses. All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups. The FDA has also updated its guidance on Device registration and listing.

Source: Medical Device User Fee Amendments (MDUFA) | FDA

Updated guidance on eCopy Medical Device Submissions | 03 October 2022

FDA has updated the guidance on electronic copy (eCopy). It is a duplicate device submission that was previously required to be sent to the FDA in paper copy format. Electronic submissions do not include electronic copies. More information on this topic can be accessed here.

Brazil

FAQ document on Software as a medical device | 19 October 2022

The document with questions and answers regarding the content of the Resolution of the Collegiate Board of Directors RDC 657/2022 is now available for consultation, which provides for the regularization of software as a medical device (Software as a Medical Device – SaMD ).

The document gathers the main questions received through the Anvisa Service System and the Fale Conosco, in order to clarify the most important points of the normative act.

Questions and answers about RDC 657/2022 can be accessed here.

Anvisa publishes a panel of Implantable Cardioverter Defibrillators | 06 October 2022

The Economic Monitoring Panel for Implantable Cardioverter Defibrillators (ICD) is now available for consultation, which covers medical devices registered with Anvisa under three technical names and allows personalized searches. The panel tends to facilitate the definition of reference prices for public or private purchases.

The resource makes it possible to group medical devices with similar characteristics, based on filters of specific technical attributes. According to the selected filter, the panel displays historical price statistics for these devices in federal public purchases, from July 2020 to June 2022, respecting the lag established by paragraph 4 of art. 22 of the Resolution of the Collegiate Board of Directors (RDC) 478/2021.

It is worth noting that the panel covers medical devices registered with Anvisa under three technical names that appear in IN 84/2021, and which had the set of technical attributes published in the annex of IN 119/2022.

The availability of the panel is part of the strategy for disseminating the results of economic monitoring of medical devices, according to RDC 478/2021.

Draft guidance for custom-made devices | 27 October 2022

The Medical Device Authority (MDA) created this guidance document to aid the healthcare community and the industry in adhering to the Medical Device Act’s (Act 737) regulations and requirements. The Medical Device Act 2012 (Act 737), Medical Device Regulations 2012, Medical Device (Duties and Obligations of Establishments) Regulations 2019, and Medical Device (Advertising) Regulations 2019 should be read in conjunction with this guidance document. Public Feedback and comments should be made by 09th November. The document can be accessed here.

India

Classification of devices pertaining to Oncology | 11 October 2022

Central Drugs Standard Control Organisation CDSCO has updated the list of oncology medical device and their classification under the Indian Medical device Rules 2017.The list includes devices like FerriScan R2-MRI Analysis System, alternating electric field antimitotic cancer treatment system generators and other devices. The list is dynamic and is subject to revision.The complete list can be accessed here.

Classification of Medical device pertaining to Dental | 10 October 2022

Central Drugs Standard Control Organisation CDSCO has updated the list of dental medical device and their classification under the Indian Medical device Rules 2017.The list includes devices like dental impression material, dental collars, dental examination kit, dental excavatos and much more. The list is dynamic and is subject to revision.The complete list can be accessed here.

Cosmetics

Brazil

Anvisa publishes guidelines on microbiological control of cosmetics | 04 October 2022

The Resolution of the Collegiate Board of Directors (RDC) 752/2022 came into force , which deals with the regularization of personal hygiene products, cosmetics and perfumes. This is the first stage of adaptation of these products. The measures are already valid for new regularizations and for labeling changes. In addition to the technical requirements and procedures for regularization, labeling and packaging, the new standard defines the parameters for microbiological control of these products. To clarify doubts regarding this item, provided for in article 28 of the RDC, and to speed up the analysis, Anvisa published Technical Note 31/2022/SEI/GHCOS/Dire3/ Anvisa.

The note provides guidelines on compliance with the mandatory technical requirement “microbiological specifications of the finished product”, where Anvisa clarifies the need to present:

  • In the case of a product susceptible to microbiological contamination, data related to the microbiological specifications of the finished product, which must meet the microbiological control parameters present in Chapter V, of RDC 752/2022; or
  • In the case of a low susceptibility product, a technical justification that demonstrates the reasons why the product has low susceptibility to microbiological contamination, suggesting, therefore, the use of ISO 29621:2017 Cosmetics-Microbiology Guidelines for the Risk Assessment and Identification of Microbiologically Low-risk Products, and its updates, as well as scientific literature relevant to the topic.

EUROPEAN UNION (EU)

EU Updates the Cosmetics Regulation Annexes | 28 September 2022

EU Commission has published Regulation (EU) 2022/1531 amending Cosmetics Regulation (EC)1223/2009, by updating Annexes II, III, and V with regards to the use of certain substances that have been classified as Carcinogenic, Mutagenic or Toxic for Reproduction (CMR). The amended regulation can be accessed here.

ISO STANDARDS

List of Updated ISO standards for October 2022

  • ISO 16976-2:2022 Respiratory protective devices — Human factors — Part 2: Anthropometrics
  • ISO 5467-1:2022 Dentistry- Mobile dental units and dental patient chairs-Part 1: General requirements
  • ISO 5467-2:2022 Dentistry- Mobile dental units and dental patient chairs-Part 2: Air, water, suction and wastewater systems.
  • ISO 7010:2019/Amd 6:2022-Graphical Symbols-Safety and colours and safety signs-Amendment 6
  • ISO 18416:2015/Amd 1:2022-Cosmetics — Microbiology — Detection of Candida albicans — Amendment 1

Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

September Newsletter 2022

EUROPEAN UNION (EU)

Notified Bodies Position paper on application of hybrid audits for QMS assessments under MDR and IVDR|26 September 2022

The latest position paper discusses the need for hybrid audits instead of the traditional on-site audits which were previously followed. The document represents the collective position on aspects to be considered while employing Information and Communication Technologies (ICT)-based auditing for quality management systems.

Manual on borderline medical devices and classification under MDR and IVDR |24 September 2022

This latest manual describes various borderline products such as nasal sprays, cosmetics, biocides, and even personal protective equipment. Following Regulations (EU) 2017/745 on Medical Devices (the MDR) and (EU) 2017/746 on In Vitro Diagnostic Medical Devices, this document details the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG) following exchanges under the Helsinki Procedure (the IVDR).

The document covers certain borderline products and the applicable regulations for making these products available on the market.

MDCG guidance on first certification of that type of device and procedure to be followed by Notified bodies|14 September 2022

The latest Medical Device Coordination Group (MDCG) guidance describes “ the first certification for that type of device”. For Class D devices, under Regulation (EU) 2017/746 on in vitro diagnostic medical devices, certain conditions when the notified body must approach an expert panel are established. These conditions are:

  • The absence of common specifications for the class D device, and
  • where it is also the first certification for that type of device.

MDGC guidance on surveillance regarding the transitional provisions under Article 110 of the IVDR| 14 September 2022

The MDCG guidance document 2022-15 describes the activities that notified bodies must carry out as part of the appropriate surveillance as described in Article 110(3) last subparagraph IVDR. This guidance document also addresses certain manufacturers’ obligations, particularly regarding their quality management system, to clarify elements to be verified by notified bodies.

FINLAND     

FIMEA update on distributor notification | 28 September 2022

According to Section 49 of the Medical Devices Act (719/2021), an operator that distributes devices to retailers, health care and social welfare operators, and other professional users, as well as other users, must notify the Finnish Medicines Agency of its operations and devices. Device notifications must be submitted by 30 November 2022.

Fimea has decided that these distributors will not be required to submit device notifications this year due to the large number of devices that need to be notified and the difficulty in keeping device notifications current. In 2023, the fee charged for distributor notification will be EUR 500.

IRELAND

HPRA Invites Clinical Experts to Join Expert panel | 23 September 2022

The HPRA is requesting clinical specialists to indicate their interest in joining a new external expert panel to contribute to the regulatory examination and assessment of medicines and medical devices. The HPRA continues to protect public health by working closely with outside clinical specialists, such as physicians, pharmacists, and other healthcare professionals.

Applications to market novel medicines that offer patients new treatment options, any emerging quality or safety concerns regarding medicines and medical devices on the market, clinical input for clinical studies and scientific advice for new products under development may all call for external experts.

Extension of the simplified registration procedure of medical devices until 2025| 23 September 2022 

The Federal Service for Surveillance in Health Care informs that Decree of the Government of the Russian Federation dated September 19, 2022 No. 1643 amended the Decree of the Government of the Russian Federation dated April 1, 2022 No. 552 “On approval of the specifics of circulation, including the specifics of state registration, of medical devices in the event of their defect or the risk of a defect in connection with the introduction of restrictive economic measures against the Russian Federation”, including in terms of extending the validity of this regulatory legal act until January 1, 2025.

The validity of medical device registration certificates issued before the Government of the Russian Federation Decree effective date of September 19, 2022, No. 1643, with a fixed expiration date of September 1, 2023, is scheduled to continue until January 1, 2025, without replacement.

Application for conduct clinical trials permit (research)| 06 September 2022

A permit must be obtained to conduct clinical trials (research) of medical devices within the Eurasian Economic Union framework. The Federal Service for Surveillance in Healthcare informs about the placement of an electronic form on the “Unified Portal of State and Municipal Services (Functions)”. To apply, the portal of public services must be used.

UNITED KINGDOM (UK)

MHRA appoints first the new UK Approved Body to certify medical devices since Brexit| 29 September 2022

To ensure that only safe and effective medical devices are distributed to UK consumers, the Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK Ltd. has joined the three other UK Approved Bodies.

Any potential organisation must go through the new designation process to be approved to certify medical devices in the UK, and DEKRA has become the first organisation to complete it. They are now recognised as a body authorised by the UK to conduct evaluations of general medical devices. The list of approved bodies in UK can be accessed here.

SWITZERLAND

Updated Swissmedic forms for medical devices and in vitro devices| 26 September 2022

The following Swissmedic forms have been updated in September:

  • Export certificates for medical devices form
  • Form for export certificates for medical devices subject to old legislation, DEVIT products and IVDs
  • Form for authorisation clinical investigation for medical devices
  • Form for Clinical investigation of research sequences on CE-marked MRI systems
  • Form for simplified review of clinical investigation of medical devices
  • Form for notification, amendment of clinical investigation of medical devices
  • Notification form of safety measures for clinical trials
  • Forms for serious adverse event (SAE) and device deficiency for medical device and in vitro diagnostics

Swissdamed- Swiss database for medical devices| 13 September 2022

Since the agreement on the mutual recognition of conformity assessments (MRA) between the Swiss Confederation and the European Union has not been updated, Swissmedic is responsible for registering economic operators (CHRN), medical devices, and in vitro diagnostic medical devices (product identification, UDI).

Swissmedic began implementation of the “Swissdamed” database in April 2022. Swiss Database on Medical Devices is known as Swissdamed. Swissdamed comprises two linked modules and a public website. It will also register economic operators in addition to medical devices.

Swissdamed will be rolled out in three releases. The first release will cover the registration of economic operators. Medical device registration will be possible after the second release. Swissmedic intends to involve selected economic operators in the realisation phase. The third release will introduce additional functions in the modules already implemented.

Event on regulations for in vitro diagnostic medical devices | 05 September 2022

The amendment to the Ordinance on Clinical Trials with Medical Devices and the new Ordinance on In Vitro Diagnostic Medical Devices (IvDO) were both approved by the Federal Council on May 4, 2022. (CTO-MedD). On May 26, 2022, the new legal requirements went into effect along with the EU’s implementation of the IVDR. Clinical studies involving in vitro diagnostic medical devices have been governed by the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) since May 26, 2022, and no longer (ClinO).

The event is primarily intended for people, businesses, and organisations based in Switzerland that produce, market, and utilise in-vitro diagnostic medical devices (IVD) and people assigned specific tasks by manufacturers based overseas. The event is set to happen on 03 November 2022.

Information sheet on Swiss single registration number (CHRN) | 30 August 2022

The latest Swissmedic information sheet on the Swiss single registration number (CHRN) contains information on the application procedure of CHRN by economic operators domiciled within Switzerland. The document also contains vital information on the obligations of operators, the payable fees and the processing time for a CHRN request.

It is essential for manufacturers placed outside Switzerland to appoint an Authorised Representative (AR) before the upcoming deadlines mentioned below.

For IVDD and IVDR devices:

Class of device Deadline
Class D31 December 2022
Class B and C31 March 2023
Class A31 July 2023

UNITED STATES OF AMERICA (USA)

FDA Guidance on Monkeypox Tests| 26 September 2022

Monkeypox virus diagnostic tests are used to establish whether a person is infected with the Orthopoxvirus, a type of virus that causes monkeypox.

The Centers for Disease Control and Prevention (CDC) offers a real-time polymerase chain reaction (PCR) test that has received FDA clearance for detecting DNA from non-variola orthopoxviruses, such as monkeypox virus: CDC Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set. There are designated CDC Laboratory Response Network (LRN) and other CDC-designated laboratories that offer the CDC test. For the non-variola Orthopoxvirus or specifically for monkeypox, laboratory-developed tests (LDTs) might also be accessible. An LDT is a specific kind of in vitro diagnostic test created, used, and maintained within a single CLIA-certified laboratory and complies with high complexity testing standards.

FDA Guidance on Electronic Submission Template 510(k) submissions | 22 September 2022

The guidance titled “Electronic Submission Template for Medical Device 510(k) Submissions” is now available, according to the Food and Drug Administration (FDA or Agency). The FDA is releasing this draft guidance to inform submitters of premarket notification (510(k)) about the resources and related content currently available to support 510(k) electronic submissions to FDA.

The electronic submission template, eSTAR, is the only currently available electronic submission template at this time to facilitate the preparation of 510(k) electronic submissions. eSTAR consists of a collection of questions, text, logic, and prompts within a template that guides a user through constructing a ‘complete’ 510(k)18 submission. The complete document can be accessed here.

FDA Guidance on eCopy Program | 23 September 2022

A compact disc (CD), digital video disc (DVD), or flash drive is used to produce and submit an electronic copy (eCopy) of your medical device submission. A paper copy of the signed cover letter is enclosed with the electronic copy. An eCopy is required for the following submission types:

  • Premarket notification submissions (510(k)s), including third party 510(k)s
  • Evaluation of automatic class III designation petitions (de Novos)
  • Premarket approval applications (PMAs), including Transitional PMAs; o This includes all PMA submission types, including, but not limited to, original PMAs, panel-track supplements, 180-day supplements, manufacturing site change supplements, 30-Day Notices, 135-Day Supplements, and post-approval study supplements and reports, as well as amendments involving changes in the correspondent or ownership and requests for extensions
  • Modular Premarket approval applications (PMAs)
  • Product development protocols (PDPs)
  • Investigational device exemption (IDE) submissions

The guidance explains the procedure for submission of eCopy, how the FDA processes it and the FDA timelines for review of electronic submission.

BRAZIL

Submission of Administrative documents through the SEI system| 22 September 2022

Anvisa notifies that starting on December 1st, all administrative papers submitted to the Agency must be handled electronically using the SEI petition. Corporate emails will no longer receive documents.

With enhanced transparency and institutional security, the orientation intends to expedite the treatment of requests and prevent duplication in processing papers. Unlike the electronic mail system, photoionisation channels offer tracking capabilities and ensure the delivery and reception of documents.

Anvisa approves the registration of the first test for the diagnosis of monkeypox in Brazil| 20 September 2022

ANVISA authorised the first product for the diagnosis of monkeypox in Brazil on September 20, 2022.

The Molecular Multiplex Kit OPXV/MPXV/VZV/RP Bio-Manguinhos is the Agency registered product. It is a product made by Fundaço Oswaldo Cruz employing a multiplex test to identify the genomic areas of the varicella-zoster, monkeypox, and orthopox viruses as well as to carry out an internal control (IC) using a human constitutive gene. the RNAseP (RP).

Clinical performance and risk management, which guarantee that the product is appropriate for the suggested use, were among the technical conditions examined by Anvisa to issue the registration. These requirements were included in Resolution (RDC) 36/2015. The examination found that the product satisfied the Agency’s technical requirements.

Anvisa updates rules for the regularisation of medical devices in Brazil| 14 September 2022

The updated text encourages the incorporation of Mercosur Resolution GMC No. 25/2021, which updated regional documentation standards and medical device categorisation guidelines at Brazil’s suggestion. In addition to internalising the standard, the document also compiles several other Anvisa laws on the regularisation of medical equipment.

Highlights of the new text are:

  • Adoption of specific classification rules for new technologies, such as Software as Medical Device and nanomaterials
  • Consolidation of notification, registration and change rules in a single RDC
  • Incorporation of rules for the Documentary Repository of Medical Devices
  • Incorporation of rules on Instructions for Use in non-printed format
  • Adoption of the Table of Contents structure (IMDRF’s Table of Contents) for Technical Dossiers, enabling the use of dossiers prepared for multiple jurisdictions (regulatory convergence)
  • Forecasting situations for stock depletion of finished products, packaging, labels, and instructions for use
  • Formalisation of the procedural reassessment procedure and
  • General modernisation of the text and updating of terminology.

The new RDC will go into effect on March 1, 2023, giving the productive sector time to amend any future applications it submits to Anvisa.

To spread awareness and prepare the industry for the new laws, seminars will be held both in-person and online for firms requesting notifications and registrations of medical devices in the second half of 2022.

SOUTH AFRICA

Guidance document on borderline medical devices| 04 August 2022

This guidance document outlines the procedure for applicants’ requests for product designation and gives applicants advice on borderline products. It reflects the South African Health Products Regulatory Authority’s (SAHPRA) current thinking regarding medical devices and medicines’ performance, quality, and efficacy. The document is published for public comment, which closes by 08 November 2022.

MALAYSIA

Guidance on licensing for the establishment of medical devices | 23 September 2022

Medical Device Authority (MDA) has issued guidance on licencing medical devices. The document gives an insight into the requirements of the Quality Management Systems (QMS), Post Market (PM) responsibilities, types of licenses provided by MDA and other important information regarding the registration of medical devices in Malaysia.

Guidance on re-registration of medical devices |15 September 2022

A medical device must be registered under Malaysia’s Medical Device Act 2012 (Act 737) before it can be imported, exported, or sold. Therefore, a medical device registration application must be submitted in compliance with Act 737 requirements and a manner decided by the Authority in Medical Device Regulations 2012 (MDR).

Medical device registration is valid for five years. After the term, the registration holder must apply for the medical device’s re-registration before it may be kept in the market or imported or exported. The guidance contains crucial information on the re-application stages, application for conformity assessment and registration fees.

Guidance document on harmonised borderline products |05 September 2022

The latest Medical Device Authority (MDA)  guidance on harmonised borderline products in ASEAN contains a list of Harmonised borderline products following the definition of medical device and agreed upon by the ASEAN Medical Device Committee (AMDC). The list contains borderline products such as Micropipettes, disinfectants for dental purposes, EDTA solutions and their classification as medical devices depending on the product usage.

Guidance document on the harmonised classification of medical devices in ASEAN|05 September 2022

Based on the manufacturer’s intended use/purpose, this guidance document provides a standardised list of risk classifications for medical devices, including in-vitro diagnostic (IVD) devices.

SINGAPORE

HSA update on potential oximeter inaccuracy | 16 September2022

The Health Sciences Authority (HSA) wants to warn consumers that people with a dark complexion may experience erroneous blood oxygen saturation readings from oximeters. Oximeter readings for these people typically show blood oxygen saturation levels greater than they are.

Oximeters are often positioned on the fingertips to calculate the percentage of blood oxygen saturation levels. To determine blood’s oxygen saturation, they use light to shine on it and measure the amount of light absorbed. Melanin, a skin pigment that may absorb both blood and the light from oximeters, is more prevalent in people with darker skin. Because of this enhanced light absorption, the oximeters may show these people’s oxygen saturation levels that are higher than they are.

INDIA

Notification on Class A medical devices licensing regime| 20 September 2022

The Medical Devices Rules (MDR), 2017, have been the subject of draft amendment rules from the ministry of health and family welfare (MoHFW), which include clauses stating the registration requirement of Class A devices under the identified online portal. As per the draft notification, registration of the devices now require the following details along with name of site and medical device details:

  • An undertaking stating the proposed device is Class A Medical Device (non-sterile and/or non-measuring)
  • Manufacturer shall self-certify that product conforms to Essential principles checklist of safety and performance of such devices.
  • The manufacturer shall self-certify to comply with the standards prescribed
  • Undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic

Guidance on Classification of non-sterile, non-powered, hand-held or hand-manipulated Surgical Instruments | 09 September 2022  

In the latest notification, Central Drugs Standard Control Organisation (CDSCO) has issued a classification of surgical Instruments for general use intended to be used in various general surgical procedures. Under this document, the following surgical devices are classified as Class A medical devices:

  • Cutting and Dissecting Surgical instruments
  • Clamping and Occluding Surgical instruments
  • Clamping and Occluding Surgical instruments
  • Grasping and Holding Surgical instruments

COSMETICS

SCPN Development to Upload Ingredients List- the United Kingdom| 09 September 2022

The OPSS, the UK’s competent authority for cosmetic products, delivered a message to registered SCPN users on September 5, 2022. Changes to the procedures for submitting alerts for cosmetic products were described in the communication.

An “enter ingredient information page” will take the place of the option to upload an ingredient-containing PDF. Users can add ingredients individually in precise or range concentrations using a new capability that takes inspiration from the EU Glossary of Cosmetic Substances. This will not impact the present frame formulation option, and businesses should continue to choose it as their preferred choice.

The revision will be put into effect on October 3, 2022. The OPSS has cautioned that this modification will remove PDFs from any notifications already in the draft form, necessitating a resubmission of the notification following the modified procedure. OPSS advises businesses to finish and submit draft notifications by September 30, 2022, and to delete any draft notifications that are no longer necessary to avoid any duplication.

UK Responsible Person Labelling Deadline Extension- the United Kingdom| 05 September 2022

The UK Responsible Person (RP) must be listed on cosmetic product labels for them to be sold in Great Britain (GB), according to information provided to CTPA by the Office for Product Safety and Standards (OPSS).

The UK Cosmetics Regulation went into effect in December 2020. A two-year grace period was set to end on December 31, 2022, at which point all goods sold in the United Kingdom would have had to comply fully with the UK Cosmetic Regulation or be removed from the market.

After carefully considering the need to list the UK RP on the product label, OPSS has decided to prolong this transitory arrangement for five years, or until December 31, 2025. Before this date, when the criteria of Article 19(1)(a) of the EU Cosmetic Products Regulation are met, the name and address of the responsible person and the country-of-origin requirements are satisfied (EU CPR). This does not account for compliance with non-EU regulations and does not relieve businesses from having to abide by the UK Cosmetics Regulation’s other requirements, such as notice and ingredient compliance. Companies are urged to make the final product label revisions during this extra period.      

UK Government Release Updated Consolidated Cosmetic Regulation Online- United Kingdom| 01 September 2022

The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 were introduced into Parliamentary proceedings by the Office for Product Safety and Standards (OPSS) on October 13, 2020. The UK Cosmetics Regulation is based on Schedule 34 of this Statutory Instrument (SI).

The UK Cosmetics Regulation (UKCR) official consolidated version is now available on legislation.gov.uk. The consolidated version considers the adjustments required to apply Great Britain (GB) market to the EU Cosmetic Products Regulation (EU CPR).

Any modifications that become effective before 31 August 2021, including any changes to the component Annexes, are considered in the current official UKCR consolidated version.

Ukraine Government postpones new Technical Regulation on Cosmetics- Ukraine| 23 September 2022

The Ukrainian government delayed the Technical Regulations on Cosmetic Products (the UA Cosmetics Regulation), which were supposed to go into effect on August 3, 2022, have been delayed to August 3, 2024, due to martial law.

Additionally, until 3 August 2026, the modification will allow the commercialisation of cosmetics that are not consistent with the UA Cosmetics Regulation. For comparison, the new UA Cosmetics Legislation includes 1,641 chemicals that are forbidden from use in cosmetics, whereas the previous regulation only listed 412. UA Cosmetics Regulation’s overarching goal is to bring Ukrainian law into compliance with EU Regulation No. 1223/2009 of the European Parliament and Council on cosmetic goods. It establishes a new regulatory framework for cosmetics, and the industry and the government must prepare for its implementation.

Application form for Saudi Free sale certificate for cosmetics- Saudi Arabia|19 September 2022

Saudi Food and Drug Authority (SFDA) has published an application form to issue a Saudi Free Sale Certificate for cosmetic products. The form must be filled out and submitted electronically to the Department of Registration of Medicines and Beauty Products via the email [email protected]. The form must be along with a fee of 200 riyals per product. The fee is subject to vary according to the product.

Anvisa approves new rules for labelling personal hygiene products, cosmetics and perfume- Brazil|14 September 2022

The Resolution of the Collegiate Board of Directors about the definition, classification, technical requirements for labelling and packaging, microbiological control criteria, and the technical processes for the regularisation of personal care goods, cosmetics, and fragrances was adopted.

By requiring mandatory minimum standards for labelling personal hygiene products, cosmetics, and perfumes to be applied by the regulatory authorities of the countries in the region, updating technical requirements following the harmonisation of Mercosur rules is a measure of regulatory convergence. It helps to reduce information asymmetry and risks associated with the inappropriate use of these products.

In this view, the goal of the regulation that the Agency authorised is to guarantee that consumers have access to accurate and up-to-date information on the features of the goods, their safety, usage, and efficacy. The RDC extends the deadline for labelling adequacy for products that have previously been regularised at Anvisa until the effective date of this Resolution until 10/03/2025. Likewise, requests for registration or labelling amendments submitted before this Resolution went into effect or that Anvisa was already analysing will be examined in line with the resolutions in place at the time of the procedure.

ISO STANDARDS

Published ISO Standards for September 2022

List of Published ISO standards for medical devices and in-vitro diagnostic devices

  • BS EN ISO 8536-3:2009+A1:2022 Infusion equipment for medical use. Aluminium caps for infusion bottles
  • BS EN 60731:2012+A1:2022 Medical electrical equipment. Dosimeters with ionisation chambers as used in radiotherapy
  • BS EN ISO 23368:2022 Anaesthetic and respiratory equipment. Low-flow nasal cannulae for oxygen therapy
  • BS EN IEC 62127-1:2022 Ultrasonics. Hydrophones. Measurement and characterisation of medical ultrasonic fields
  • ISO/FDIS 15189 Medical laboratories — Requirements for quality and competence

List of Published ISO standards for cosmetics

  • ISO 11930:2019+A1:2022 Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product — Amendment 1
  • ISO 16128- 2:2017+A1:2022 Cosmetics — Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients — Part 2: Criteria for ingredients and products — Amendment 1     
  • ISO 16212:2017+A1:2022 Cosmetics — Microbiology — Enumeration of yeast and mould — Amendment 1
  • ISO 18415:2017 +A1:2022 Cosmetics — Microbiology — Detection of specified and non-specified microorganisms — Amendment 1
  • ISO 21149:2017+A1:2022 Cosmetics — Microbiology — Enumeration and detection of aerobic mesophilic bacteria — Amendment 1
  • ISO 21150:2015+A1:2022 Cosmetics — Microbiology — Detection of Escherichia coli — Amendment 1
  • ISO 22717:2015 +A1:2022 Cosmetics — Microbiology — Detection of Pseudomonas aeruginosa — Amendment 1     
  • ISO 22718:2015 +A1:2022Cosmetics — Microbiology — Detection of Staphylococcus aureus — Amendment 1
  • ISO 23674:2022 Cosmetics — Analytical methods — Direct determination of traces of mercury in cosmetics by thermal decomposition and atomic absorption spectrometry (mercury analyser)    
  • ISO 23821:2022 Cosmetics — Analytical methods — Determination of traces of mercury in cosmetics by atomic absorbtion spectrometry (AAS) cold vapour technology after pressure digestion

Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

 

August Newsletter 2022

EUROPEAN UNION (EU)

MDCG guidance on Notified body capacity and availability of medical devices and IVDs |26 August 2022

The MDCG acknowledges that there are still significant and urgent challenges to be overcome to ensure that manufacturers are prepared and that notified bodies have enough capacity to certify medical devices and in vitro diagnostic medical devices following the EU MDR and the IVDR within the transition periods specified in the Regulations. According to the information acquired thus far, there are several causes, and a variety of solutions are needed.

MDCG lists some measures to increase the capacity of the informed body manufacturers’ readiness and access to notified bodies to facilitate the transition to the MDR and IVDR and to prevent a medical device shortage. Some of the points mentioned in the guidance are listed below:

  • Use of hybrid audits
  • The utilisation of a framework for evidence from previous assessments under the directives to prevent any duplication of work
  • Combining audits under directives and MDR/IVDR for Surveillance of legacy devices and focussing on the compliance of requirements set out by MDR/IVDR
  • Standard fees of notified bodies to be made available for public
  • Schemes for Small-to-medium enterprise manufacturers and first-time applicants

Expert decision and opinion on CECP|24 August 2022

Expert decision and opinion of the Clinical Evaluation Consultation Procedure (CECP) of tricuspid valve replacement system in the latest announcement released by the European Commission. As per the document, notified bodies are required to consider the opinions expressed in the scientific opinion of the expert panel, particularly when those experts find the level of clinical evidence to be insufficient or have significant reservations about how to balance benefits and risks, whether the clinical evidence is consistent with the intended use, including any medical indications, or with the post-market clinical follow-up (PMCF) plan.

Public consultation on reclassification of products without an intended medical purpose |11 August 2022

EU regulations on medical devices cover products without a medical purpose. For a complete list, see Annex XVI to Regulation (EU) 2017/745. Examples include laser or intense pulsed light devices for hair removal or skin treatment, liposuction tools, and brain stimulation devices.

As a result of this initiative, such devices will be subject to the same pre- and post-market regulations as comparable medical devices and will be classified following their risks. The commission encourages the public to give feedback on this initiative. More information on the consultation can be found here.

The consultation is open until the 08th of September 2022.

MDCG guidance on designation, re-assessment and notification of conformity assessment bodies and notified bodies| 10 August 2022

This document is intended to guide the authorities in charge of notified bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs) when conducting assessments of conformity assessment bodies (CABs) that apply for designation as a notified body (NB) in the field of medical devices and in vitro diagnostic medical devices, and ii. re-assessments of NBs.

Furthermore, this guide is intended to bring consistency and alignment to the working practices of the various designating authorities in the Member States in terms of CAB and NB assessment, designation, notification, and re-assessment.

European Commission publishes calls for European Union Reference Laboratories for IVDs designation| 05 August 2022

The European Commission has issued a call for Member States to submit applications on behalf of candidate EU Reference Laboratories for IVDs (EURLs). EURLs will be critical in batch testing and verifying the performance of high-risk (Class D) in vitro diagnostic medical devices (IVDs).

CZECH REPUBLIC

Seminar on Obligations of manufacturers of devices under MDR | 22 August 2022

State Institute for Drug Control is organising a seminar on manufacturer obligations under MDR on 14th September 2022. The seminar also covers essential topics such as:

  • Road to Regulation of the European Parliament and the Council (EU) 2017/745 (MDR)
  • Validity and transitional periods
  • New requirements resulting from the MDR
  • New requirements resulting from Act 89/2021 Coll.
  • Quality Management System (QMS)
  • Market Surveillance
  • Steps to MDR Implementation       

For more information on the registration, click here.

FAQ Document on device advertising | 08 August 2022

The Department of Medical Devices has issued a new document with the answers to some of the questions from the seminar on medical device advertising. The seminar discussed the various aspects of advertising healthcare devices and in vitro diagnostic devices. The document contains information on topics such as prerequisites for healthcare devices website, places for providing medical devices and IVD samples and others. The document can be accessed here.

GERMANY

Guidance on the authorisation procedure for performance studies and clinical trials | 17 August 2022

The Federal Institute for Drugs and Medical Devices (BfArM) has issued guidance on the authorisation procedure for performance studies and clinical trials of In vitro diagnostics and medical devices. As long as the central European database EUDAMED does not provide the corresponding functionality, the application is submitted via the German Medical Devices Information and Database System (DMIDS, formerly DIMDI) of the Federal Institute for Drugs and Medical Devices (BfArM). 

Per the guidance, a performance study can only be commenced if BfArM has not objected within 10 days of validating the clinical study application. Further information on clinical trials and performance studies can be found here.

Guidance on notification of Other Clinical Investigations | 17 August 2022

The federal institute for Drugs and Medical Devices (BfArM) has issued guidance on other clinical investigations. The guidance is specific to those investigations that are:

  • Not part of a systematic and planned device development or device surveillance process of a current or future manufacturer,
  • Not carried out to demonstrate the conformity of a device with the requirements of Regulation (EU) 2017/745,
  • Serve to answer scientific or other questions; and
  • Conducted outside a clinical development plan referred to in point 1(a) of Part A of Annex XIV to Regulation (EU) 2017/745.

The guidance also shares the procedures to be followed in case of a temporary halt or early termination of a clinical investigation.   

Reporting channels according to MDR and MPDG| 17 August 2022

The Federal Institute for Drugs and Medical Devices (BfArM) has issued guidance on reporting channels until the European Database for Medical Devices is fully operational. Until now, only some essential modules of the EUDAMED are available for registration and notification of medical devices and IVDs. The guidance lists the reporting channels, designated email IDs and the method for Notifications, applications, and reports.

UNITED KINGDOM (UK)

MHRA event on adverse event reporting | 21 August 2022

The following is a summary from a recent MHRA webinar on the new Manufacturer Online Reporting Environment (MORE) used to report vigilance incidents to MHRA.

The new system will go into effect from September and November of 2022, with a final extension for some occurring in April 2023. Between September and November, manufacturers, authorised representatives, and UK responsible persons must upgrade their IT systems and SOPs so that you can register to use the new system (Please note that the exact dates have not been announced).

Manufacturers will be able to create a new MORE account from September, and can be used once MHRA has approved it. The current MORE portal will be decommissioning from November. The present API mailbox will be shut down in April 2023. A test environment will be made available for volunteers interested in utilising the new API.

The new MORE will be a part of the MHRA’s new Safety Connect system and will be linked to other MHRA IT systems and their present Appian device registration system, which handles device registration. The new system will be based on MIR7.2 (the current version of the EU Manufacturer Incident Report form). It is unclear whether or when the MHRA will implement the upcoming MIR7.3 or which version will be used in Northern Ireland, even though the MHRA stated they seek to be compatible with a similar EU system (EUDAMED).

SWITZERLAND

Swiss MedTech event on MDR product certification| 31 August 2022

All MDD/AIMD certificates must be updated by the MDR’s deadline of May 26, 2024. Only 1000 of the 25000 certificates that were cleared by the Notified Bodies (NB) under MDR have been done so yet. The event will be held on 06th September 2022 and will discuss the MDR certification and the documentation requirements to be followed.

Swissmedic Information sheet on clinical investigations of medical devices| 26 August 2022

In the latest information sheet on clinical investigation of medical devices, Swissmedic introduces the application and authorisation procedure of clinical investigation. The review and surveillance of the investigation are also mentioned in the document.

Recommendations on the use of guidance documents released by MDCG | 21 August 2022

The Medical Devices Coordination Group (MDCG) employs guidance documents to assist stakeholders in implementing medical device regulations. MedTech Europe’s position paper explains how these documents should be used without impeding manufacturers’ efforts to comply with the new MDR and IVDR regulations. The paper will now be forwarded to the European Commission, the MDCG, the CAMD, and the notified bodies by MedTech Europe. The entire document can be accessed here.

Updated Swissmedic forms for IVD registration | 08 August 2022

Swissmedic has published an updated form for the product registration of Swiss In vitro diagnostic devices IVD manufacturers under Art. 90 of In Vitro Diagnostics Ordinance (IvDO). Swissmedic has also updated its guidance on performance studies of IVDs.

AUSTRALIA

Post-market review of ventilators, CPAP and BiPAP devices| 23 August 2022

All devices listed in the Australian Register of Therapeutic Goods (ARTG) that fall under the following categories are undergoing post-market reviews by the Therapeutic Goods Administration (TGA) right now:

  • Continuous and non-continuous ventilators
  • Acute care ventilators
  • Ambulatory ventilators, including continuous positive airway pressure (CPAP) devices and
  • Bi-level positive airway pressure (BiPAP) devices

This post-market review identifies risks posed by a polyester-based polyurethane (PE-PUR) foam used as soundproofing material in ventilator, CPAP and BiPAP devices. The review aims to ensure that devices included in ARTG meet essential principles set out in Therapeutic Goods Regulations 2002 and to confirm that the devices are safe for use.         

Australian regulatory guidelines for medical devices (ARGMD)| 19 August 2022

The Australian Regulatory Guidance for Medical Devices (ARGMD) is the regulatory body for medical devices in Australia.

Information required with applications to import, export, manufacture, or supply medical devices in Australia is outlined in the ARGMD. The ARGMD likewise covers the post-market specifications for medical devices. It does not provide regulatory advice on other medicinal devices listed or registered. These products are governed by the Australian Medical Device Requirements Under the Therapeutic Goods Act 1989 (version 4), or DR4, posted on the TGA website.

TGA is currently reviewing and updating the Australian Regulatory Guidelines for Medical Devices (ARGMD). The previous version of ARGMD can be found here. The presentation on the new TGA website can be found in this here.

Guidance document on active medical device requirements | 19 August 2022

The TGA has released a document on active medical device requirements. An active medical device uses and converts significant energy to function. The form of energy used by an active device does not include gravitational or directly provided human energies. The document further discusses different active devices, the application of electromedical safety standards and some specific software requirements.

Consultation on proposed regulatory changes for clinical trials of medical devices| 17 August 2022

The Therapeutic Goods Administration (TGA) is seeking feedback on proposed regulatory changes to improve clinical trial safety oversight for medical devices:

  • To improve regulatory oversight of clinical trials of specific unapproved, high-risk medical devices.
  • Clinical trials of all medical devices should be included in Australia’s Good Clinical Practice Inspection Program (to enable selected trials and documentation supporting these trials to be inspected).

Opening date of consultation: 17 August 2022

Closing date of consultation: 28 September 2022

The consultation document can be accessed here.

Guidance document on the exemption for specific clinical decision support software| 17 August 2022

This guidance offers a thorough understanding of the exemption requirements for specific CDSS and is intended for sponsors, manufacturers, suppliers, and software developers of Exempt Clinical Decision Support Software (CDSS). Exempt software is a medical device but is not required to be included in the Australian Register of Therapeutic Goods (ARTG). The broad CDSS guideline that the TGA released in February 2021 is supplemented by this paper.

The Government revised the Therapeutic Goods (Medical Devices) Regulations 2002 in February 2021 to include new standards for software-based medical devices and clarify certain current ones. Based on the following guidelines, several software-based medical devices were exempted (either through an exception or exclusion) from the TGA regulation:

  • Alignment with international regulatory frameworks where appropriate
  • Reduce or remove unnecessary regulatory burden: by not regulating products where there is no significant risk to safety and where suitable frameworks for product or system oversight are already in place.

Post-market review of antigen and rapid antigen tests| 04 August 2022

The Australian Register of Therapeutic Goods (ARTG) includes all COVID-19-specific laboratory antigen tests and rapid antigen tests (RATs), including point-of-care and self-testing (ARTG). With ongoing work to evaluate their capacity to identify new variations, the review’s goal is to ascertain whether SARS-existing CoV-2’s known variants have influenced tests.

All point of care (PoCT) and self-test RATs included in the ARTG are also subjected to laboratory testing as part of the post-market evaluation to confirm their effectiveness in identifying the Delta and Omicron variants (and other emerging variants of concern).

SARS-CoV-2 virus mutations result in a variation of the virus, which may change the structure of the produced viral protein. Test kits can then lose their ability to identify the virus, producing false-negative findings accurately.

Manufacturers of these tests have given the TGA study data, including recombinant protein studies, live viral studies, inactivated virus studies, and clinical trials, to confirm the effectiveness of their test kits.

Application for priority applicant determination – medical devices| 02 August 2022

A form must be completed and submitted to apply for a priority applicant determination for a medical device(s), along with sufficient supporting information addressing the relevant eligibility criteria.

Please review the Priority applicant guidelines for medical devices before submitting your application (including IVDs). These guidelines describe the application process, the device’s criteria to be considered a priority applicant, and how to pay the application fee. To access the form, click here.

UNITED STATES OF AMERICA (USA)

Medical Device Shortage List Updated By FDA| 26 August 2022

The Food and Drug Administration (FDA) has published a list of device shortages to notify the public, especially those who use or purchase medical devices. The list is required by law to be kept and updated as the COVID-19 public health emergency develops and reflects the categories of devices the FDA has judged to be in low supply. It also satisfies a requirement under section 506J of the FD&C Act. Including a particular device type on this list does not imply that patient care has been adversely affected.

The F.D.A. removed surgical respirators from the device shortage list. In addition, the F.D.A. expanded the list of devices to include two brands of needles and syringes (product code G.A.A.) and two brands of viral transport media (product codes QMC and J.S.M.). The complete list can be accessed here.

FAQ Document On 3D Printing of Medical Devices, Accessories, Components & Parts During Covid-19 Pandemic| 26 August 2022

In response to COVID-19, the F.D.A. continues to take innovative and adaptable strategies to address the issue of access to essential medical items. Because of the increased demand and general disruptions to the worldwide supply chain during the COVID-19 pandemic, the requirement for certain medical items, particularly personal protective equipment (P.P.E.), may exceed the supply available to healthcare organisations. F.D.A. has issued a new document that answers frequently asked questions for organisations that 3D print gadgets, accessories, parts, and components during the COVID-19 emergency. The guidance can be accessed here.

FAQ document on Testing for SARS-CoV-2 | 26 August 2022

The F.D.A. recently released a new document responding to frequently asked questions about Emergency Use Authorizations and Notifications as outlined in the Policy for Coronavirus Disease-2019 Tests.

Federal Register on Medical Device Labelling Regulations | 23 August 2022

The Food and Drug Administration (FDA) seeks public opinion on the available information. This notice requests feedback on the rules governing the labelling of medical devices.

The information gathering process aids in applying section 502 of the FD&C Act’s medical device labelling regulations. Medical device labellers are mandated by the Global Unique Device Identification Database (GUDID) to design and use medical device labels and device packages that bear a Unique Device Identification (UDI), present dates on labels in a specific format, and submit data regarding each version or model of a device no later than the date the label of the device must bear a UDI. Respondents will be expected to update the information submitted if the information changes whenever a device is subject to UDI regulations.

eMDR System Enhancements| 22 August 2022

The FDA’s eSubmitter software is part of an electronic submissions process that is available for voluntary use by sponsors, manufacturers, and importers to create various submission types within the drug, blood, device, radiological health, tobacco, animal drug and animal food regulated industries. Although the FDA eSubmitter client is updated simultaneously with the eMDR system, industry with system-to-system, or AS2, accounts with the FDA Electronic Submissions Gateway (ESG) should utilise the information on this page to schedule system changes to coincide with these eMDR system advancements as soon as practicable.

The FDA is aware of how critical it is to give manufacturers who send HL7 ICSR XML reports through AS2 early warning and predictability about anticipated eMDR system modifications. As a result, the FDA has decided to announce and implement updates to the eMDR System annually.

Guidance on Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products | 16 August 2022

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) apply specific legal standards for hearing aids and personal sound amplification products (PSAPs), which are included in this guidance. Confusion among stakeholders and customers has been exacerbated by the absence of distinction between PSAPs and hearing aids.

As per the guidance, both hearing aids and PSAPs impact a user’s hearing, but the products are subject to various regulatory controls because of their varied intended uses. Unlike hearing aids, which are meant to help someone with hearing loss or make up for it, PSAPs (defined in Section III) are not meant to identify, mitigate, or treat impairment. They are not meant to alter the structure or functionality of the body, only to treat or prevent disease. Therefore, they are not regarded as “devices” because the term is used in the FD&C Act.

Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices| 16 August 2022

The FDA revised its “Replacement Reagent and Instrument Family Policy” for in vitro diagnostic (IVD) devices in 2003 and published it as a guidance. The 2003 guidance outlined a procedure for manufacturers to follow when adapting an assay that had previously been cleared based on performance characteristics when used with a particular instrument to a different instrument that was either cleared or a member of an instrument family from which another instrument had previously been cleared. When evaluated against predefined acceptance criteria using an appropriate validation protocol, manufacturers established sufficient control through the method outlined in the 2003 guidance to maintain the level of safety and effectiveness demonstrated for the cleared device for these types of modified devices without submitting a premarket notification (510(k)).

As FDA continues to advocate for the prompter availability of a wider variety of clinical laboratory tests for patient benefit, FDA feels that this guideline is crucial for public health. This guideline encourages uniform implementation of the ideas in this advice by updating and clarifying the Replacement Reagent and Instrument Family Policy for manufacturers of IVD devices and FDA staff.

Federal Register on Medical Devices: Ear, Nose, and Throat Devices | 16 August 2022   

To modernise the regulatory environment for hearing aids, the FDA is creating a regulatory category for over-the-counter (OTC) hearing aids and implementing associated changes. In particular, FDA defines OTC hearing aids and establishes relevant requirements; modifies current rules to be consistent with the new OTC category; repeals the conditions for sale that apply to hearing aids; modifies the current labelling requirements for hearing aids; and updates regulations relating to decisions on applications for exemption from Federal pre-emption that will become null and void due to changes to the hearing aid requirements. By establishing a regulatory category for over-the-counter (OTC) hearing aids and revising current regulations, the FDA hopes to encourage access to and innovation in the field of hearing aid technology while reasonably assuring these devices’ safety and efficacy.

Federal Register on the Modifications to the List of Recognised Standards, Recognition List Number: 058| 9 August 2022

The set of criteria that the Food and Drug Administration acknowledges for use in premarket evaluations will soon be updated, according to the latest publication of the FDA. Manufacturers that want to declare conformance with consensus standards can benefit from this publication, “Modifications to the List of Recognised Standards, Recognition List Number: 058,” which details the criteria for medical devices.

The FDA is making announcements on the addition, removal, correction, and amendment of a few consensus standards that the Agency acknowledges for use in premarket filings and other device requirements. The FDA Recognised Consensus Standards list in the Agency’s searchable database has been updated to reflect these changes. FDA refers to the current revisions as “Recognition List Number: 058.”

Evaluation of Automatic Class III Designation (De Novo) Summaries| 09 August 2022    

The De Novo classification option was added as an alternative pathway to classify novel medical devices that had previously been automatically placed in Class III after receiving a “not substantially equivalent” (NSE) determination in response to a premarket notification [510(k)] submission by the Food and Drug Administration Modernization Act of 1997 (FDAMA). On July 9, 2012, section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA) revised section 513(f)(2) of the FD&C Act to permit a sponsor to submit a De Novo classification request to the FDA without first being required to submit a 510(k) application.

For innovative low- to moderate-risk device categorisation, there are two choices.

  • Anyone who obtains an NSE finding in response to a 510(k) submission may submit a De Novo request for the FDA to conduct a risk-based review for classifying the device into Class I or II within 30 days of receiving the NSE determination.
  • Anyone who decides there are no lawfully marketed devices on which to base a judgement of substantial equivalent may file a De Novo request to the FDA to classify the device into Class I or II based on risk, without first filing a 510(k) and receiving an NSE determination.

Guidance on Colour Additives for Medical Devices| 08 August 2022         

Under certain circumstances, the same rules that govern colour additives in foods, medicines, and cosmetics also apply to colour additives in medical devices. According to Section 721(a) of the Food, Drug, and Cosmetic Act (the Act), devices containing a colour additive is deemed adulterated unless a regulation specifies the colour additive’s intended use. The colour listing regulation may allow the colour additive to be used in a general-purpose device, like contact lenses, or it may impose restrictions on its use, like using polypropylene nonabsorbable sutures only for general surgical procedures and not for ophthalmic procedures. The definition of colour additive and the specific links to the regulation can be accessed here.

Updated Guidance on Breast Implants| 08 August 2022 

The FDA has taken several new actions to improve breast implant risk communication and assist those considering breast implants in making informed decisions.

First, the FDA issued orders limiting the sale and distribution of breast implants to help ensure that patients thinking about getting breast implants are given enough risk information to make fully informed decisions.

Second, the FDA approved new labelling that says the following for all legally marketed breast implants:

  • Boxed warning
  • To make sure the patient is aware of the risks, advantages, and other details associated with the breast implant device, the healthcare provider must go over the patient decision checklist with the potential patient. The patient decision checklist must be initialled by the patient and signed by both the doctor implanting the device and the patient
  • Updated recommendations for screening for breast implant ruptures filled with silicone gel
  • A detailed description of the device along with a list of its specific components
  • Patient Device card

Further reading on the topic can be accessed here.

Updated guidance on Breakthrough devices program| 03 August 2022

The Breakthrough Devices Program is a voluntary programme for specific medical devices and device-led combination products that offer more efficient treatment or diagnosis of fatal or permanently crippling diseases or conditions.

The purpose of the Breakthrough Devices Program is to expedite the development, evaluation, and review of these medical devices while maintaining the legal requirements for premarket approval, 510(k) clearance, and De Novo marketing authorisation, in line with the Agency’s mission to safeguard and advance public health. The updated guidance now contains breakthrough device program metrics.

Updated guidance on Sterilisation of medical devices| 03 August 2022        

Various sterilisation techniques are used to clean medical equipment, including steam, dry heat, radiation, ethylene oxide gas, vaporised hydrogen peroxide, and other sterilisation techniques (for example, chlorine dioxide gas, vaporised peracetic acid, and nitrogen dioxide). FDA has released a statement on its efforts to support innovation in medical device sterilisation.

SAUDI ARABIA

SFDA publishes updated forms for medical devices| 08 August 2022 

Saudi Food and Drug Authority (SFDA) has issued updated forms for medical device manufacturers.

A list of updated forms includes:

  • Corrective action implementation plan
  • Field safety closure report
  • Risk assessment
  • Clinical investigation
  • Device malfunction report
  • Device accident report.

JAPAN

Webinar on Implementation of IMDRF documents in the Japanese Regulations| 22 August 2022

The Pharmaceuticals and Medical Devices Agency (PMDA) is organising the “PMDA-ATC Medical Devices Webinar 2022 – Implementation and Adaptation of Japanese Medical Device Regulation based on GHTF/IMDRF documents”. The Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) will offer the webinar. Key objectives of the webinar include:

  • Regulations of specific medical devices, especially in IVD medical devices, AI-based medical devices, High risk (Classes C and D) medical devices and software as a Medical Device (SaMD)
  • Up-to-date information about some specific medical devices.

SINGAPORE

HSA update on Paclitaxel-Coated Devices for Peripheral Arterial Disease | 22 August 2022

Peripheral arterial disease (PAD) typically arises when blood flow to the limbs is restricted due to plaque buildup in the arteries. In patients with PAD, paclitaxel-coated balloons (PCB) and paclitaxel-eluting stents (PES) are used to open the stenotic or blocked vessel. These devices release paclitaxel to lessen the likelihood of re-stenosis in the treated artery.

A comprehensive analysis of randomised controlled trials (RCT) published in 2018 revealed an increased risk of death at 2 to 5 years following the use of PCB and PES devices to treat PAD.

Considering this research, HSA released anannouncement advising medical professionals to:

  • Continue monitoring patients who have received paclitaxel-coated devices for PAD using the most recent standards of medical care
  • When considering using such devices, weigh each patient’s clinical benefits and risks.

INDIA

List of notified bodies under MDR |25 August 2022

Central Drugs Standard Control Organisation (CDSCO)has issued a list of Notified bodies under MDR. The document has an updated list of notified bodies registered with CDSCO that can carry out the audit of a manufacturing site. The complete list can be accessed here.

List of certified medical device testing labs under MDR |17 August 2022     

Central Drugs Standard Control Organisation (CDSCO)has issued a list of Medical Device testing laboratories to carry out tests on behalf of the manufacturer. There are about 18 device test labs till 07th December 2021. The document has an updated list of laboratories, the registration number, and the scope of tests available in the specific lab. The complete list of Medical Device testing laboratories can be accessed here.

Classification of medical devices pertaining to Rehabilitation under Medical Device Rule 2017| 04 August 2022    

Central Drugs Standard Control Organisation (CDSCO) has updated its list of medical devices for rehabilitation. The requirements of the Drugs and Cosmetics Act of 1940 govern the safety, quality, and performance of medical devices. The Central Government has notified Medical Devices Rules (MDR) for regulating medical devices in import, production, clinical evaluation, sale, and distribution, following consultation with the Drugs Technical Advisory Board. The updated list of medical devices under MDR includes acupressure calf band and Arthritis TENS system, among other medical devices that aid rehabilitation. The complete list of medical devices and the product class can be accessed here.

Draft guidance on In vitro Diagnostic Medical devices | 07 July 2022

CDSCO has released draft guidance on the overview of performance evaluation, stability studies and post-market surveillance of In vitro Diagnostic Medical Devices. The draft guidance is out for public comment. The complete document can be accessed here.

COSMETICS

FAQ document on registration for import and manufacture of cosmetics – India|17 August 2022

The Cosmetics Rules, 2020, have been published with effect from 15.12.2020. On commencement of these new cosmetic rules, the office has received various concerns and challenges faced by the stakeholders regarding application for grant of import registration certificates and subsequent endorsements. Therefore, to streamline the process of import registration of cosmetics and address these issues, it has been decided to provide detailed clarification on these issues. Accordingly, an additional set of FAQs (annexed) have been prepared considering the Cosmetics Rules 2020 for information of all the stakeholders. The full document can be accessed here.

Restriction of Use of Methyl N-Methyl anthranilate (MNM) in Cosmetic Products- Saudi Arabia|22 August 2022  

Saudi Food and Drug Authority has issued circular 24366 on the restriction of the use, including regulating the use of (Methyl N-Methyl anthranilate (MNM) in cosmetic products. The circular comes ineffective from the 07th of January 2022. After evaluating the latest evidence and studies, the authority decided that it is allowed to add Methyl N-Methyl anthranilate (MNM) in rinseable cosmetic products. Rinse-off products can contain quantities not exceeding 0.2%. Circular also puts in place the following restrictions:

  • Do not use nitrosating agents cosmetics:
  • Maximum nitrosamine content: 50 µg/kg
  • Keep in nitrite-free containers

SFDA guide to reporting, recalls, and manufacturing errors for cosmetic products | 22 August 2022 

The latest guide released by the Saudi Food and Drug Authority (SFDA) introduces the requirements for cosmetic products. The guide includes the details from side effects caused by certain cosmetic ingredients to reporting side effects and the timelines for reporting to be followed by manufacturers. The below table describes the reporting timeframes to be followed once users report side effects.

Type of errorMaximum Reporting Timeframe
Product recall10 Days
Serious side effects or manufacturing fault20 days

ISO STANDARDS

Published ISO Standards for August 2022

List of Published ISO standards for medical devices and in-vitro diagnostic devices

  • BS EN ISO 11608-1:2022 Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems
  • BS EN ISO 11608-2:2022 Needle-based injection systems for medical use. Requirements and test methods. Double-ended pen needles
  • BS EN ISO 11608-3:2022 Needle-based injection systems for medical use. Requirements and test methods. Containers and integrated fluid paths
  • BS EN ISO 15798:2022 Ophthalmic implants. Ophthalmic viscosurgical devices
  • PD ISO/TR 12417-2:2022 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products. Local regulatory information
  • BS EN ISO 10942:2022 Ophthalmic instruments. Direct ophthalmoscopes
  • BS EN ISO 8980-3:2022 Ophthalmic optics. Uncut finished spectacle lenses. Transmittance specifications and test methods
  • BS EN ISO 10079-3:2022 Medical suction equipment. Suction equipment powered from a vacuum or positive pressure gas source
  • ISO/TS 5798:2022 In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) by nucleic acid amplification method

List of Published ISO standards for cosmetics

  • ISO 24442:2022 Cosmetics — Sun protection test methods — In vivo determination of sunscreen UVA protection

July Newsletter 2022

EUROPEAN UNION (EU)

Harmonised administrative practices and alternative technical solutions| 13 July 2022

The MDCG guidance document advises the Member States and other relevant parties on applying specific IVDR regulations in the absence of Eudamed. This guidance defines harmonised administrative processes and alternative technology alternatives for information interchange until Eudamed is entirely operational. Based on the appropriate provisions of Directive 98/79/EC, this guidance covers specific instances when information exchange would be difficult, if impossible, to execute.

Implementation of Regulation (EU) 2022/1107 for common specifications under Regulation (EU) 2017/746| 5 July 2022

The European Commission has established common standards for high-risk diagnostics, including HIV tests and SARS-CoV-2 assays. The guidelines establish uniform and stringent criteria for tests across the EU, clarifying the requirements for market participants and protecting EU patients. Annexes I to XIII of EU Regulation 2022/1107 specify the various standards to be met by Class D in vitro diagnostic medical devices in terms of performance characteristics. Annex XIII defines the standards for devices that detect or quantify markers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The EU Regulation 2022/1107 can be accessed here.

ITALY

Webinar on “CLV of cosmetic products – procedures and critical issues”| 11 July 2022

An online event titled “CLV of cosmetic products – procedures and critical issues” is organised by the Directorate General for Medical Devices and Pharmaceutical Service – DGDMF (Office 8) and is targeted at businesses in the industry interested in applying for Certificates of Free Sale (CLV) for “export of cosmetic products.” To know more on the topic, click here.

UNITED KINGDOM (UK)

Updated Guidance on Registering Medical devices in UK| 28 July 2022

Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on medical device registration in the UK. The guidance now contains a specific Coronavirus Test Device Approval (CTDA) section. Persons planning to supply, put into service, or place a coronavirus test device on the UK market must apply for clearance from the UK’s Health Security Agency (UKHSA).

The MHRA will not accept registration applications for covid test devices until they have received Coronavirus Test Device Approval (CTDA) or are placed on the Temporary Protocol list.

Over 285,000 medical devices and medicines seized in UK | 20 July 2022

In the latest press release by the Medicines and Healthcare products Regulatory Agency (MHRA), over 285,000 illegal drugs and medical devices were seized. The MHRA have seized large quantities of illegally traded medicines and medical devices in an Interpol week of action known as “Operation Pangea”.

Over £850,000 in medicines and medical devices, totalling over 285,000 items, have been seized by officers from the UK’s MHRA as part of a global operation to combat the illegal sale of medical products, with UK seizures estimated to be worth around 9% of the global total.

Guidance on Innovation Accelerator | 26 July 2022

Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the Innovation accelerator, which aims to provide access to MHRA’s scientific expertise, regulatory assistance, and enhanced advice and signposting service for inventors and developers of novel products. It provides regulatory information, advice, and guidance to organisations of all sizes and backgrounds based in the UK or globally (industry, academics and patient groups).

The Innovation Office is open to queries from those developing innovative medicines, medical devices, manufacturing processes and blood components for transfusion.

Public consultation on future regulation of medical devices | 26 June 2022

MHRA has released a document on the future regulation of medical devices in the UK by MHRA. The document contains feedback from a wide demographic, including healthcare professionals and manufacturers. The highlights of this document include:

  • Possible reclassification of medical devices increased post-market surveillance of medical devices
  • Implementation of improved traceability of medical devices
  • Government to introduce Alternative market routes
  • Rescheduled CE marked devices acceptance and UKCA dates.

SWITZERLAND

New EUDAMED information Center launched | 21 July 2022

The European Commission has launched the new EUDAMED Information Center. It combines all EUDAMED Production User Guides, offers rapid and organised access to all relevant information, and includes a contact form for users to contact the EUDAMED Support Team. For more information, click here.

MedTech Europe Survey Report on MDR implementation| 20 July 2022

MedTech Europe performed a study with 475 responses from major and small businesses to quantify medical device availability. According to the findings, less than 15% of medical equipment has previously gained MDR certification. The time to certification has increased to 13-18 months, and more than 15% of SMEs still do not have access to an MDR-designated Notified Body. As a result, over half of respondents believe they will deprioritise the EU market for new device regulatory approval. The report discusses how MDR implementation will affect the EU medical device market.

Swissmedic information sheet on in-vitro diagnostic device notifications | 14 July 2022

Swissmedic has released an updated document on in vitro diagnostic medical devices. The information sheet answers some of the frequently asked questions on IVD notification. The document contains information on when the notification form for IVDs must be submitted, the timeline for processing the application and other important information.

AUSTRALIA

Unique Device Identification system: Communications and stakeholder engagement| 18 July 2022

The success of the UDI system needs to involve health professionals, healthcare organisations, consumers, and industry in its creation and implementation. The TGA will interact and consult with stakeholders to ensure that all viewpoints, notably those of medical device users, are considered. The TGA’s public reporting will guarantee that the TGA’s progress toward establishing the UDI system is transparent. Click here to access the latest webinar on UDI implementation.

Safety information on home use fetal dopplers (heartbeat monitor) | 07 July 2022

The TGA is now studying foetal cardiac monitors’ safety indicators, advantages, and disadvantages for home use. This review is shared with consumers and healthcare professionals. The TGA’s examinations will help assess whether utilising these gadgets carries more risk than the potential benefit.

Fetal dopplers are handheld devices that track the foetal heart rate between 10 and 12 weeks of pregnancy. Traditionally, health workers have employed these tools in clinical settings. Fetal dopplers for home usage have become readily accessible recently, and users don’t need special training to use them. The TGA is aware of instances in which Fetal dopplers for home use have led to patients receiving delayed medical care and false reassurance. The Royal Australian and New Zealand College of Obstetricians and Gynecologists and the US Food and Drug Administration (US FDA) have released guidelines on using these monitors. Both do not encourage the usage of home doppler equipment to detect the foetal heartbeat.

UNITED STATES OF AMERICA (USA)

Patient Labelling Recommendations for Laser-Assisted In Situ Keratomileusis (LASIK) Lasers | 27 July 2022

The content and formatting for patient labelling information for laser-assisted in situ keratomileusis (LASIK) devices are recommended in this guidance document. This guidance is to help ensure that both physicians and patients understand the benefits and dangers of these devices. The recommendations are issued in response to concerns that some patients are not receiving or understanding information about the benefits and hazards of LASIK equipment. The labelling suggestions mentioned in the document are meant to supplement, not replace, physician-patient discussions about the advantages and dangers of LASIK devices that are unique to patients.

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices | 22 July 2022

In this guidance, the FDA modified the Global Unique Device Identification Database (GUDID) submission requirements for several class I devices considered consumer health goods. In particular, the FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I devices requiring a UDI on their labels and device packages because they are deemed consumer health items. Furthermore, the FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices, before December 8, 2022, regardless of whether they are consumer health products (an additional 75 calendar days).

Medical Device Types for Section 506J Notification Obligation | 19 July 2022

FDA has updated the guidance containing suggestions based on the device types and corresponding product codes for manufacturers when they are required to notify FDA during the COVID-19 pandemic under section 506J. Section 506J of the FD&C Act requires manufacturers to notify the Secretary of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of specific devices that leads to a disruption in the supply of that device in the United States.

FDA has listed the device types and their corresponding product codes so that manufacturers can consider whether they are required to notify FDA during the COVID-19 pandemic under section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Tracking Premarket Submission’s Progress (Progress Tracker) | 18 July 2022

The Center for Devices and Radiological Health’s (CDRH) progress in assessing Traditional, Abbreviated, and Special 510(k) applications is tracked by the FDA using a secure, web-based tracker. Official Correspondent can now track the FDA’s progress online when you submit a 510(k) submission to CDRH for review in a clear, concise manner.

The FDA provides online progress tracking to uphold its obligations under the Medical Device User Fee Act (MDUFA). The application tracker can be accessed here.

510(k) Third Party Review Organization Performance Report for FY22 – Q3| 8 July 2022

The FDA Modernization Act of 1997 (FDAMA) established the Accredited Persons Program to enhance the effectiveness and timeliness of the FDA’s 510(k) procedure. As part of the programme, the FDA accredits Third Parties (Accredited Persons) qualified to perform the initial 510(k) reviews for admissible devices.

In accordance with MDUFA (Medical Device User Fee Act) IV, the FDA committed to publicly making online the performance of each accredited Third Party with at least five successfully submitted documents (e.g., the specific number of holds and the typical turnaround time for decisions). Every quarter, a summary of Third-Party Performance Metrics will be published. Data from FY 2018, Q1 through FY 2022, and Q3 are included in this study (October 1, 2017, through June 30, 2022). The report can be accessed here.

COSTA RICA

Health reform decree to simplify the registration of low-risk processed foods and cosmetics| 06 July 2022

The sanitary registration of processed foods and low-risk cosmetics will be made easier by an amendment to executive decree 43291-S. The operation, which formerly took 30 days to complete, must be finished immediately. According to Minister of Health Joselyn Chacón Madrigal, the purpose of this kind of reform is to make the nation more competitive to draw investment and facilitate business through digital governance. The list of cosmetic items has also been expanded to include items for the face (moisturising creams, masks, and powders), mouthwash, and alcohol solution for hand cleansing.

BAHRAIN

Bahrain Health Regulatory Conference on 27-29 September 2022| 26 June 2022

The National Health Regulatory Authority (NHRA) will hold Bahrain’s 2nd Health Regulatory Conference. Government healthcare decision makers, health reform and regulation experts, pharmaceutical and drug company owners, public and private healthcare providers, investors and interested experts in the healthcare business, technology experts, solution providers, and healthcare professionals will all be present at the exhibition. The exhibition will take place from 27th -29th September 2022.

This is an opportunity to exchange knowledge and thoughts while participating in an educational platform.

CHINA

China approves new domestically developed ‘artificial heart’| 17 July 2022

“Artificial heart” for severe heart failure developed in China has received commercial permission from the NMPA of China.

The TEDA International Cardiovascular Hospital and the China Academy of Launch Vehicle Technology collaborated to develop the artificial heart; they have been researching the third generation of ventricular assist devices in China since 2009.

According to the Annual Report on Cardiovascular Health and Diseases in China (2021), published in late June, there are 8.9 million heart failure patients in China. According to the report, 58 of the 68 medical devices that the NMPA authorised to join its “innovative medical device evaluation channel” between September 2020 and August 2021 were Chinese.

MALAYSIA

Full enforcement of medical devices regulations 2019 from July 2022| 01 July 2022

Malaysia’s Medical Device Authority (MDA) has announced that the Medical Devices Regulations 2019 will be implemented entirely from July 1, 2022.

With full enforcement of this Regulation, all parties involved in the importation, distribution, and placement of medical devices on the market are required to comply with all of the requirements set out in this Regulation, which generally set out post-market control requirements, such as complaint handling, mandatory problem reporting, corrective and preventive actions in the field (field corrective action) and recall for medical devices. Further information regarding labelling can be found here.

SINGAPORE

Consultation on Regulatory Guidelines for Laboratory Developed Tests (LDTs | 01 July 2022

An updated version of the Regulatory Guidelines for Laboratory Developed Tests (LDTs) has been made available by the Medical Devices Cluster (MDC) for stakeholder consultation. Under the Healthcare Services Act, clinical laboratories are currently subject to MOH regulation and licencing (HCSA). Considering the present regulatory requirements that apply to clinical laboratories under HCSA, the regulatory approach for LDTs will be based on the current regulatory standards applicable to commercial in-vitro diagnostic devices (IVDs).

The document provides an overview of the scope of LDTs and the regulatory requirements applicable, including Product controls, Manufacturing Quality controls and Post-market controls.

JAPAN

Health Science Council Pharmaceuticals and Medical Devices System Subcommittee to be held on 05 August 2022| 22 July 2022

A Subcommittee will be held on the 5th  of August 2022. The agenda includes:

  • Discussions on the revised Pharmaceuticals and Medical Devices Act
  • Working group on the work of pharmacists and the functions of pharmacies
  • Others relevant topics

Study Group on Early Introduction of Medical Devices with High Medical Needs will be Held | 20 July 2022

This study group aims to identify in-vitro diagnostic medications and medical devices with significant unmet medical requirements that are not licenced or indicated in Japan and to consider their fast introduction into clinical practice.

INDIA

Notice regarding non-notified medical devices | 11 July 2022

According to notification No. G.S.R. 102(E) dated 11.02.2020, all non-notified medical devices in the Class A and Class B categories are expected to enter the licencing regime by October 1, 2022. For Class A and Class B medical devices, a transition period of 30 months from the date of introduction of G.S.R. 102(E), i.e., 01.04.2020, has been provided for the transfer to the licencing regime.

In the notice, CDSCO strongly recommends that all manufacturers apply for a manufacturing licence for Class A and Class B medical devices using CDSCO’s online portal so that the manufacturing licence can be obtained from the various State Licensing Authorities following a review of the applications and audit.

Classification of medical devices pertaining to Rehabilitation under Medical Device Rule 2017| 06 July 2022

The requirements of the Drugs and Cosmetics Act of 1940 govern the safety, quality, and performance of medical devices. The Central Government has notified Medical Devices Rules (MDR) for regulating medical devices in import, production, clinical evaluation, sale, and distribution, following consultation with the Drugs Technical Advisory Board. The updated list of medical devices under MDR includes acupressure calf band and Arthritis TENS system, among other medical devices that aid rehabilitation. The complete list of medical devices and the product class can be accessed here.


Please note: Always refer to the regulations in the respective ministry of health website for authorised news and releases.

June Newsletter

 

EUROPEAN UNION (EU)

Guidance document on the implementation of EU product rules 2022 | 29 June 2022

The ‘Blue Guide’ on EU product rules 2022 (Document Number (2022/C 247/01). This guidance discusses both non-food and non-agricultural products, referred to as products for use by consumers or professionals. It applies to medical and in-vitro diagnostic devices that comply with Regulation (EU) 2017/745 and Regulation (EU) 2017/746. It covers various topics such as the actors in the supply chain, product requirements and market surveillance of products in the EU market.

Notice to manufacturers to ensure timely compliance with MDR requirement| 13 June 2022

The regulatory framework for medical devices and in vitro diagnostic medical devices (IVD) has altered dramatically after the introduction of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). Five years have passed since their adoption. The document is a notice to manufacturers to ensure the timely compliance of medical devices with the deadlines.

The document further explains that the MDR will fully apply to all medical devices on May 27, 2024. Therefore, manufacturers are responsible for ensuring that their devices comply with the MDR once the transition period ends. Medical devices that have not been certified under the MDR will no longer be able to enter the EU market after that date.

CZECH REPUBLIC

CAMD Statement on the transition to MDR and the capacity of the medical device system | 20 June 2022

Following the debate on the transition to MDR and the capacity of the medical device system during the French Presidency of the EU Council, the CAMD (Committee of Competent Authorities for Medical Devices) adopted a statement at its 50th plenary session. The statement can be found here.

1. CAMD is aware of the significant and pressing issues in establishing enough capacity and preparedness for all stakeholders with proper regulatory infrastructure by May 2024. So far, the research reveals that there are various causes and no single remedy. Finding solutions is a collaborative effort.

2. CAMD recognises that if these issues are not resolved promptly, they may cause disruptions in the supply of products to health systems and patients and impede the introduction of novel medical devices into the European market.

3. When addressing urgent capacity concerns, the CAMD believes it is equally critical to explore and resolve root causes.

Relocation of seminar on Obligations of custom-made ZP manufacturers under Regulation (EU) 2017/745 of the European Parliament and of the Council| 07 June 2022

Due to a low number of participants, the seminar “Obligations of makers of custom-made ZP according to Regulation (EU) 2017/745 of the European Parliament and of the Council” scheduled for 16.6.2022 has been postponed to September 2022. The new seminar date will be announced well in advance, and those who have already registered will be contacted personally.

Performance studies on Register of Medical Devices | 30 May 2022

With regard to the postponed launch date of the EUDAMED database, the IVDR includes transitional provisions that allow the use of the Register of Medical Devices (hereinafter referred to as “RZPRO”) for agendas that will be carried out in the future through the EUDAMED database.

These transitional provisions for IVDR provide that, until the performance study module is fully operational, the RZPRO shall be used for the application, notification and registration of SFZs, the notification of substantial changes and the reporting of serious adverse events arising during the SFZ. The new SFZ reporting module has already been launched in RZPRO and can already be used for these purposes. Notification of SFZ will be carried out from the effective date of the IVDR according to the requirements of this legal regulation. This also impacts the reporting of performance studies (from now on referred to as “SFZ”).

FINLAND

Presentations on clinical investigations of medical devices have been published on Fimea’s website | 1 June 2022

On May 17, 2022, Fimea hosted a research webinar to address the changes brought about by new EU laws to the application and notification processes, application materials, and clinical assessment of medical devices and in vitro diagnostic medical devices. Other subjects covered were national legislative requirements and Fimea regulations for clinical investigations and performance studies conducted in Finland.

The webinar presentations, as well as the questions and answers posted on the chat forum during the webinar, are now available on Fimea’s website and can be accessed here.

IRELAND

CAMD publish plenary meeting statement and certificates of free sale Q&A document| 22 June 2022

The Competent Authorities for Medical Devices (CAMD) issued a statement regarding the transition to the Medical Devices Regulation (MDR) and the capabilities of the medical device system.

In this statement, the CAMD:

(1) Recognizes the urgent challenges relating to sector capacity and readiness ahead of May 2024 (notified body certificates issued in accordance with previous directives will become void from this date), which, if left unaddressed, may affect the supply of critical and innovative devices to the EU market.

(2) Outlines their commitment to collaborate with EU colleagues and key stakeholders to find solutions to these difficulties and avert supply interruptions.

(3) Agrees that solutions should focus on getting producers on the right track to compliance rather than reinterpreting MDR requirements or derogations given by national competent authorities.

(4) Requests that work on finding answers to these problems be expedited.

HPRA Guide on the Performance Studies Conducted in Ireland| 16 June 2022

This HPRA Guidance is intended to assist sponsors and other stakeholders in preparing to implement the IVDR’s Performance Study (PS) requirements. Performance studies are regarded to be carried out in the Republic of Ireland if the study:

  • site is based in the Republic of Ireland,
  • participants/specimens originate from the Republic of Ireland.

In general, several PS in Ireland require an application or notification to the HPRA under the IVDR. Section 3 has further information. It is worth noting that some PS require two forms of review, one from a National Competent Authority for in vitro diagnostic medical devices and another from a relevant Research Ethics Committee. In Ireland an ethics opinion can be sought from the National Office for Research Ethics Committees; further information can be found on the NREC website (www.nrecoffice.ie)

HPRA notification on Substantial Modification of a Clinical Investigation of a Medical Device| 08 June 2022

If the sponsor wishes to make changes to a clinical investigation in Ireland that are likely to have a significant impact on the subjects’ safety, health, or rights, or on the robustness or reliability of the clinical data generated by the investigation, they must notify the HPRA at least 38 days before implementation with notification form for substantial modification of a clinical investigation.

ITALY

Establishment of the mandatory national register for breast prosthetic implants | 03 June 2022

In the session on May 26, 2022, the State-Regions Conference expressed support for the draught decree establishing the National Register of Breast Prosthetic Implants. Regional and provincial registries will feed the national breast implant registry. The registry will contribute to the independent assessment of the safety and long-term performance and traceability of breast implants throughout the national territory.

Regional and provincial registries will feed the national breast implant registry. The register will aid in the impartial assessment of the safety, long-term performance, and traceability of breast implants across the country. The record will allow the regions and autonomous provinces to conduct clinical monitoring of the patient receiving implantation and recall him if necessary or subject him to specific follow-ups.

UNITED KINGDOM (UK)

UK to strengthen regulation of medical devices to protect patients| 26 June 2022

The MHRA has issued a press release outlining intentions to strengthen medical device regulation to increase patient safety and foster innovation. The MHRA intends to modernise medical device regulation to improve patient health and foster innovation.

The UK is seizing the opportunities provided by leaving the EU to bring forward new legislation that goes further to improve people’s health. The UKCA label will be used to indicate that products have met these world-class requirements.

MHRA joins international partnerships to set global standards for medicines and medical devices regulation| 16 June 2022

The MHRA announced its acceptance as a full member of three international work-sharing partnerships. In the press release issued by MHRA, intentions to strengthen medical device regulation to increase patient safety and foster innovation is outlined. Through these collaborations, the MHRA will share experience with other prominent organisations, assist in the development of regulatory guidelines, and promote better regulatory harmonisation around the world.

UNITED STATES OF AMERICA (USA)

Establishment Registration and Device Listing for Manufacturers and Importers of Devices | 23 June 2022

The Office of Management and Budget (OMB) has received a proposed collection of information from the Food and Drug Administration (FDA) for evaluation and clearance in accordance with the 1995 Paperwork Reduction Act. Medical device establishment owners and operators must electronically submit establishment registration and device listing information in accordance with section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) and its implementing regulations in 21 CFR part 807, subparts A through D.

To achieve several statutory and regulatory objectives, such as:

  • identifying establishments manufacturing marketed medical devices.
  • identifying establishments manufacturing a specific device when that device is in short supply or is required for a national emergency.
  • facilitating recalls for devices marketed by owners and operators of device establishments; and
  • identifying an establishment that produces a specific device, complete and accurate registration and listing information is required.
  • managing post-marketing surveillance programmes for devices.
  • identifying those that have been illegally promoted.
  • identifying and controlling those that have been imported from outside; and
  • arranging inspections of registered businesses in accordance with section 704 of the FD&C Act.

Guidance on Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures | 21 June 2022

The FDA’s suggestions for non-clinical performance testing to support premarket submissions for gynaecologic and general laparoscopic power morcellation containment systems are included in this draft guidance document. These are used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so that the tissue can be removed through a small incision site. It may also assist manufacturers in adhering to the special controls for non-clinical performance data for these devices. This advice offers suggestions on:

  • test procedures,
  • test parameters, and
  • test acceptance standards and is applicable to tissue containment systems utilised during a power morcellation operation for both gynaecologic and general application.

The recommendations are meant to encourage uniformity and allow effective consideration of applications for general and gynaecologic laparoscopic power morcellation containment systems. The suggestions are being made to make sure that non-clinical test methods can efficiently uncover safety risks connected to damage to the tissue containment system and subsequent leakage of any cancer cells and other contents.

Additionally, the FDA is advising manufacturers to provide more precise information on the risks of usage as they pertain to age, the danger of spreading both benign and malignant uterine tissue, and the use of LPM containment systems in the labelling for these devices. The product labelling guidance are meant to supplement, not to replace, the doctor-patient conversation about the advantages and disadvantages of using LPMs that are particular to each patient.

Information about Consensus Standards | 07 June 2022

The Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21, Code of Federal Regulations (21 CFR), Parts 1-58, 800-1299, both contain regulatory rules that apply to medical devices marketed in the US. The risk associated with the device determines the regulatory controls required to ensure a reasonable assurance of safety and efficacy, as well as the marketing channels. Premarket Notification (510(k), De Novo Classification Request, Exempt, Premarket Approval (PMA), Product Development Protocol, Humanitarian Use Exemption, and Biologics License Application are some of the marketing channels (BLA).

A device can be commercialised in four steps:

  • Classify your device and comprehend the relevant regulatory controls.
  • Select and complete the appropriate premarket submission
  • Send your Premarket Submission to the FDA and Communicate with FDA Staff During Review
  • Comply with Applicable Regulatory Controls, Including the Establishment Registration and Device Listing.

BRAZIL

Update of instructions for use of medical devices: understand| 06 June 2022

Updates to instructions for use resulting from needed approval changes should be posted to the medical device document repository only when the appropriate change requests have been approved and published.

Regularization processes for products that obtain updated instructions for use with information originating from requests for modification of approval necessary prior to their approval and publishing indicate an irregularity in the product registration process. As stated in Article 6 of The Collegiate Board Resolution (RDC) 431/2020, “companies that submit information that does not conform with current legislation and consistency with the regularised product are liable to the penalties set for in Law No. 6,437/1977.”

Anvisa technical note on ozone therapy technology in medical devices| 06 June 2022

Anvisa has received multiple requests for the regularisation of medical devices emitting ozone for a variety of purposes. In this regard, the Agency has recently issued a technical comment on ozone therapy technology used in medical devices.

The document includes the Agency’s current list of indications for medical equipment. This includes:

  • Dentistry: antimicrobial action in the treatment of dental caries
  • Periodontics: prevention and treatment of inflammatory/infectious conditions
  • Endodontics: potentiation of the sanification phase of the root canal system
  • Dental surgery: aid in the process of tissue repair;
  • Aesthetics: aid in skin cleansing and asepsis;

Anvisa webinar addresses software regularization as a medical device| 01 June 2022

On June 13th, 2022, Anvisa hosted a virtual seminar to highlight the key topics of The Collegiate Board Resolution (RDC) 657/2022, which provides for the regularisation of software as a medical device (Software as a Medical Device – SaMD). Participants will be able to clear up any misconceptions about the subject of software regularisation.

New standard on CBPF medical devices comes into force| 01 June 2022

Anvisa informs that the Resolution of the Collegiate Board (RDC) 687/2022, which specifies the conditions for granting or renewing the Certification of Good Manufacturing Practices (CBPF) of medical devices, goes into effect on 01st June 2022. RDC 183/2017 is superseded by this standard. Furthermore, the new resolution intends to clarify the issues frequently presented by the former norm, such as those regarding plant plants susceptible to certification. Another innovation is the publishing of Anvisa’s risk matrix utilised in the certification process, which attempts to increase transparency and predictability in the productive sector.

AUSTRALIA

Post-market review of antigen and rapid antigen tests| 22 June 2022

The TGA is reviewing all COVID-19 specific laboratory antigen tests and rapid antigen tests (RATs), including point-of-care and self-tests, included in the Australian Register of Therapeutic Goods (ARTG). With ongoing work to evaluate their capacity to identify newly developing variants, the review’s goal is to ascertain whether tests have been impacted by the known variations of SARS-CoV-2 at this time.

All point of care (PoCT) and self-test RATs included in the ARTG are also subjected to laboratory testing as part of the post-market evaluation to confirm their effectiveness in identifying the Delta and Omicron variants (and other emerging variants of concern).

SARS-CoV-2 virus mutations result in a variant of the virus, which may change the structure of the produced viral protein. Test kits can then lose their ability to accurately identify the virus, producing false-negative results.

Manufacturers of these tests have given the TGA study data, including recombinant protein studies, live virus studies, inactivated virus studies, and clinical studies, to validate the effectiveness of their test kits.

TANZANIA

Notice to traders of treatment equipment on use of customer accounts when applying permits through the system – online portal| 06 June 2022

TMDA notified the medical devices purchasers about the checking of their accounts for medical devices and reagents they have registered in the TMDA accreditation application system, which is accessible at mis2.tmda.go.tz/portal.

It was discovered throughout the review that some consumers had been using several accounts on the system. Due to the customer’s inability to see their registered products on the system, they choose to send the request in a customised order, which slows down the application processing and ultimately delays the issue of permits.

Customers who have several accounts must advise TMDA of which accounts should be used and which ones should be closed before June 30, 2022. To send the information, use the email address [email protected].

In order to guarantee their quality, safety, and efficacy, the Authority also wants to implore all of its clients who purchase medical supplies and reagents to register their goods before they are imported.

SAUDI ARABIA

Updates on the compliance timeframe for Unique device identification in Saudi Arabia| 06 June 2022

The latest guidance from SFDA on unique device identification requirements (Saudi-DI) for medical devices mentions the timeframe for the implementation of UDI on the various device classes. Saudi has released the SFDA UDI database for all medical devices. The below table shows the compliance dates that must be followed.

Compliance timeframe
Launching the UDI database and starting optional registration01 October 2020
Risk ClassCompliance date
Class D 01 September 2023
Class B and Class C01 September 2023
Class A01 September 2024

BAHRAIN

Mandatory of using QR code for reporting Medical Devices complaints| 29 June 2022

In this circular, the National Health Regulatory Authority ( NHRA ) emphasises the importance of using the QR code and placing it in a prominent location for simple reporting of medical device complaints in order to ensure the quality of medical devices and the safety of patients and users. This is to ensure the safety of their use and maintenance in order to ensure patient safety.

INDIA

Classification of Dental, Obstetrical and Gynaecological Under the provision of Medical Devices Rules 2017| 06 June 2022

Safety, quality, and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940. The list of dental products now regulated under the Medical device rules 2017 is given in this document and the Obstetrical and Gynecological products can be accessed here.