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.

Vigilance in EU MDR

Vigilance in EU MDR

Introduction

The Medical Device Vigilance System’s goal is to lower the risks of using medical equipment and serious incidents while it strives to improve protection for patients, healthcare providers, and other users. A National Competent Authority Report is one way that adverse occurrences are evaluated and, where necessary, information is shared according to the Medical Devices Directives/Regulations (NCAR). The implementation of suitable field safety corrective measures aims to prevent the repetition of such events. To facilitate and harmonise the execution of the EU regulations on Medical Devices by manufacturers and competent authorities, general recommendations on vigilance are added to the Medical Devices Regulations.

Manufacturers of medical devices are obligated by law to report adverse incidents and Field Safety Corrective Actions (FSCAs) to EU Competent Authorities in accordance with the European Medical Devices Regulations and the In-Vitro Diagnostic Devices Regulations. Regulators are frequently perplexed by the “when, what, and to whom” part of EU incident reporting. Companies that disclose incidents incorrectly risk serious repercussions. RA professionals must take the initiative because ignorance is not a valid justification for failing to report problems.

Requirements for Vigilance Reporting According to EU MDR 2017/745

The following events are considered as “reportable events” in accordance with the new EU MDR when they directly involve a medical device:

  • The event resulted in death or a severe decline of the health of the patient, user, or any other person involved.
  • Although the specific event had no adverse effects on any individual, it could result in death or a severe decline of the health of the patient, user, or any other individual if it were to occur again. The manufacturer is responsible for determining whether a given occurrence could seriously impact a patient or user; this assessment must be based on risk management and a medical examination of the particular event.

The Timeline For Vigilance Reporting (as per MDR ARTICLE 87)

  • Events that pose a serious risk to public health must be notified immediately but no later than two days after becoming aware of them.
  • Events involving the death of a patient, a user, or any other person, or the serious deterioration of their health, must be notified immediately but no later than 10 days after becoming aware of them.
  • Events that had little or no impact on the patient or user but were likely to result in death or a major decline in health if they happened again must be reported right away but no later than 15 days after becoming aware of them.

When are EU vigilance reports necessary?

In accordance with MEDDEV 2.12/1, an incident report must be made if a device malfunction, decline in device performance, inadequate instructions, or inadequate labelling results in death or serious injury, or if it could result in death or serious deterioration of state of health if it were to occur again. The incident has to be notified to the member state’s Competent Authority (CA), depending on where it happened.

In Europe, below are the fundamental procedures to report an incident:

  • The appropriate reporting deadline, which will depend on the severity of the incident, can be found in MEDDEV 2.12/1.
  • Notify the relevant Competent Authorities of the incident.
  • Respond to Competent Authorities’ inquiries on the devices implicated, their time on the market, and any design alterations.
  • Appropriate communication with the Competent Authorities and determine whether a Field Safety Corrective Action (FSCA) and Field Safety Notice (FSN) are required.
  • Send a Final Incident Report or a FSCA Report to the appropriate authorities.
  • Include vigilance reports in ISO 13485 or equivalent quality system records and any correspondence with Competent Authorities.
  • Unless Class 1 self-certified, report any accidents or FSCAs to the respective Notified Body.

Vigilance as per EU MDR compared to the MDD

It was challenging to distinguish between Vigilance and PMS in the Medical Device Directive (MDD). In the European Union Medical Device Regulation (EU MDR), a distinction is made between “post-market surveillance” (PMS), which is the periodic reconfirmation that the benefits of the device continue to outweigh its risks, and “vigilance,” which is the identification, reporting, and trending of serious incidents and the conduct of safety-related corrective actions.

The 10-day limit for reporting a death or a major health deterioration and the 2-day reporting deadline for serious threats to the public’s health have not changed since the MDD. The MDD’s 30-day reporting deadline for all other reportable occurrences is replaced by a 15-day reporting deadline for all other major incidents.

When the frequency or seriousness of additional incidents significantly increases, the EU MDR also mandates vigilance reporting. As opposed to the MDD, trend reporting (Article 88) and analysis (Article 89) were already directed by MEDDEV 2.12/1 and had been anticipated by European Competent Authorities and Notified Bodies for some time.

The necessity to submit vigilance reports to the EUDAMED database (Article 92), as opposed to each national Competent Authority, as required under the MDD, is a new requirement in the EU MDR. The national vigilance reporting methods will continue to be used, though, until the vigilance module of EUDAMED is available.

FAQs

To Whom Should Medical Device-Related Incidents Be Reported?

Medical device-related adverse events must be reported to the relevant national competent authorities where they occurred.

EU IVDR’s First certification for the type of IVD and Notified bodies procedures

EU IVDR’s First certification for the type of IVD and Notified bodies procedures

A short article based on MDCG 2021-22 guidelines on “first certification for the type of devices and the corresponding procedures to be followed by the Notified Bodies, ” established based on Article 106 of Regulation 2017/745  for Class D IVDR devices.

Additionally, this guide talks about the conditions to be followed by the Notified bodies, whether to consult the expert panel for the performance evaluation report of the IVDR devices.

  • If the type of the device comes under the first certification in the market (AND)
  • There is no CS for the class D devices.

According to Article 48(6) of IVDR 2017/746, the first certification for the type of device means that the product has no similar product with the same intended use or technology around the European market. Also, the notified bodies should submit the performance evaluation report to the expert panel within five days of receiving it from the manufacturer. The same intended purposes include

  • Device functions like monitoring, diagnosing, screening etc.
  • If the device is quantitative, semi-quantitative or qualitative
  • It is automated or semi-automated, or not
  • If it is used for any measurement
  • If the device is used for any specific disorder
  • What is the specimen type, or if it is applicable for some testing purpose
  • What all the intended users
  • Or if the device has the same principle of operation

Suppose the device has met the above-mentioned purposes under Directive 98/79/EC or has an ongoing consultation with the expert panel under EU 2017/746. In such case, the notified bodies need not consult the expert panel for the certification.

However, if the class D device is with similar intended purpose but one of the devices has some additional intended purpose along with the common intended purpose, which falls outside Rule 1 or 2 of IVDR Annex VIII then, this type of device should be considered under the “type of device” while consulting the expert panel.

Other examples for the same type of purposes include

  • Automated and semi-automated devices
  • Technologies
  • Multiplex and single analyte devices
  • Kits and class D components of those kits
  • Control materials

Hence, the notified body issuing the certificate should check if the product meets the criteria stated above to classify it as the “type of device” for the first time. For the final decision, they can use their knowledge and expertise, consider the information provided by the manufacturer, or if the device has already undergone an expert panel consultation. Post assessments, if the notified bodies decide that the product is given the first certification, they need to consult the expert panel and document the certification with the conclusion.

Table

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Fig 1: Notified body template for the expert consultation 

If the expert panel has been kept in consultation for the first certification of the IVDR device, the notified body cannot issue the second or third certificate without considering the views of the expert panel on the type of device. 

What are class D IVDR devices? 

Class D devices are high-risk devices, including devices used for blood screening for grouping, to screen cells & organs to manage infectious outbreaks or for transplantation. 

What is an expert panel? 

Expert panel advisors are appointed by the EU commission who can provide scientific, technical, and clinical evaluation guidance for high-risk devices and their performances. 

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

EU MDR Market Surveillance Activities

EU MDR Market Surveillance Activities

Market surveillance is the activity carried out by the competent authorities according to Article 93 of MDR 2017/745 to ensure that products on the market comply with the relevant laws and regulations and with the current EU health and safety requirements. Maintaining market security in Europe and promoting consumer safety and business trust is vital.

Suppose the medical device poses an unacceptable risk to the health or safety of the patients, users, or other people or any other aspects of the protection of public health. In that case, the competent authorities shall immediately require the manufacturer of the medical devices concerned, its authorized representative (AR), and all other relevant economic operators to take appropriate and duly justified corrective actions to bring the device into compliance with the MDR Regulation or withdraw or recall the medical device from the market.

Depending on the severity of the incident, the regulatory authorities require reports of serious adverse events or accidents to be submitted within 48 hours to 15 days. The most crucial aspect of market surveillance efforts is the evaluation and examination of the adverse event or incidence investigation reports, risk management reports, and vigilance data from medical device manufacturers and consumers.

If they disagree with the national legislation notified, they must immediately communicate their complaints to the European Commission and the other Member States via the electronic system referred to in Article 100 of MDR. Any measures taken by a Member State that has not been objected to by either a Member State or the Commission within two months of receiving the notification are justified.

If necessary, the authority may start a public field safety corrective action (FSCA). For significant product non-conformities, the responsible authority must evaluate if further regulatory action is necessary, which can be taken by destroying hazardous or non-compliant products, confiscating medical equipment, or assisting the manufacturer in bringing the product back into compliance with the law.

Obligations of the competent authorities are

  • Monitoring devices and incidents that occur while using them
  • Analyzing market data and identifying the possible potential issues
  • Reviewing technical documentation
  • Identifying unsafe or non-compliant medical devices
  • Reactively or proactively inspecting economic operator facilities
  • Removing unsafe devices from the market

The competent authorities shall develop annual surveillance activity plans and allocate adequate materials and qualified human resources to carry out those activities above. Also, they shall prepare a summary of the surveillance activities performed with the required corrective action to be set out by the economic operators and make them available on the electronic system.

The Member States will review and evaluate the effectiveness of their market surveillance efforts, which are carried out at least every four years, and be informed to the Commission and other Member States of their outcomes. Each Member State must summarise the results available to the public via the electronic system, as mentioned in Article 100 of MDR 2017/745.

The electronic system EUDAMED shall collate and process the following information on market surveillance.

  • Surveillance activity results
  • Final inspection report
  • Unacceptable risks associated with the medical devices
  • Non- compliance product information
  • Results of reviews and assessments carried out by the Member states on market surveillance.

To ensure a high-quality and uniform level of market surveillance across all Member States, the competent authorities must coordinate their market surveillance efforts through joint market surveillance activities, work together, and share their results with one another and the Commission.

What is the difference between Post-market Surveillance (PMS) and Market Surveillance?

Market surveillance is the same as post-market monitoring, where they make sure that medical devices sold on the EU market are safe, effective, and compliant. Market monitoring is conducted by the appropriate competent authorities, whereas the manufacturer of the medical devices carries out PMS.

What is the role of vigilance in market surveillance activities?

Vigilance focuses on reporting serious adverse events or accidents and field safety corrective actions (FSCA). In contrast, market surveillance is entirely concerned with developing procedures that can ensure the compliance of medical devices.

Any serious incident involving a device marketed and sold in the European Union and any field safety remedial action carried out in the EU or other markets where the device is sold should be made available in EUDAMED.

What is a joint action of market surveillance?

The Joint Action on Market Surveillance of Medical Devices (JAMS) is created to strengthen market surveillance across European member states. The medical device industry carries out best practices, education, information, and resources to improve public health protection. Critical goals include enhancing coordination and assisting member states with limited resources in building their capacities and skills in the market surveillance network. It will facilitate the creation of clinical processes, equivalent resources, and a consistent and balanced approach to manufacturer inspections.

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.