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.
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.
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
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:
- Standards and Conformity Assessment Program
- How Consensus Standards Can Be Used in Premarket Submissions
- FDA Standards Recognition Process
- Recognized Consensus Standards Database
- Non-Recognized Standards
- Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Other Standards and Conformity Assessment Program Activities
- Resources for Standards and Conformity Assessment Program
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.
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.
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.
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.
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
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.