Medical Devices-USA/Europe Regulatory News Roundup, Nov 2022

EUROPE

1. Updated information pack for candidate EU reference laboratories published
Regulation (EU) 2017/746 empowers the European Commission to designate one or more EU reference laboratories for specific devices, or a category or group of devices or for specific hazards related to a category or group of devices. To do this, the Commission will launch a call for applications for designation of EU reference laboratories to Member States.
A candidate laboratory cannot submit an application directly to the European Commission. It has to submit the application to the relevant Member State and the Member State will submit the application to the European Commission. A Member State can submit applications to the European Commission only for candidate laboratories located on its territory.

2. 19th update – Common list of COVID-19 antigen tests
Category A and Category B devices
The EU common list of COVID-19 antigen tests has been split up in two categories:

• Category A: Antigen tests for which their performance has been evaluated through prospective clinical field studies and that meet the criteria agreed on 21 September 2021 have been placed under the “A-category” of the EU common list.
• Category A.1 sets out the eligible COVID-19 rapid antigen tests and Category A.2 sets out the eligible COVID-19 laboratory-based antigenic assays.
• Category B: Antigen tests for which their performance has been evaluated through retrospective in vitro studies and that meet the criteria agreed on 21 September 2021 have been placed under the “B-category” of the EU common list. Category B.1 sets out the eligible COVID-19 rapid antigen tests and Category B.2 sets out the eligible COVID-19 laboratory-based antigenic assays.

UK (MHRA)

3. List of medical devices that are no longer covered by an exceptional use authorisation
To ensure transparency around the supply of medical devices in the UK, MHRA is now providing a list of manufacturers and devices that are no longer covered by an exceptional use authorization.
Exceptional use authorisations will be issued directly to the manufacturer of the medical device and normally do not allow for distributor sales.

4. Borderline products: how to tell if your product is a medical device and which risk class applies
Some products are hard to distinguish from a medical device. These products are called borderline products until their status has been decided.
The MHRA determines whether a product falls within the definition of a medical device and provides information on whether a product is a medical device or not. The MHRA also determines whether a product is a medicine or not.

5. Medical devices given exceptional use authorisations during the COVID-19 pandemic
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

IRELAND (HPRA)

6. Outcome of the Process – Public Consultation on proposed Human Medicines, Compliance fees, Medical Device fees and Veterinary Medicines for 2023
The public consultations on proposed fees 2023 for Human Medicines, Medical Device and Compliance fees and Veterinary Medicines fees closed on 29 October.
The HPRA’s primary objective is the protection of public health but in delivering this HPRA is committed to providing a first class service to the industry we regulate. HPRA will continue to review the cost base of the HPRA and related fees. As always, HPRA commit to reviewing our fees annually to ensure that the fee levels are appropriate to the functions and costs of the HPRA. Consequently, as HPRA is required to cover their costs with fee income, HPRA propose to submit the fee structure as outlined in the original consultation document to the Minister for Health and the Minister for Agriculture, Food and the Marine for approval.

7. MDR and IVDR regulatory information published by the HPRA
HPRA has published a new website section, which provides information in one central location on the Medical Devices Regulation and the In Vitro Diagnostics Regulation. The information is relevant to industry stakeholders, including manufacturers, authorised representatives, importers and distributors working to implement the Regulations.
The new website section includes newly published guidance on a number of key topics and collates previously published topics together for ease of reference. The new structure aims to make it easier for stakeholders to navigate and locate our regulatory information.

CANADA (HC)

8. Summary reporting provisions of the Medical Devices Regulations: Notice to industry
Health Canada understands that some of you are finding it difficult to implement the summary report provisions within the required timelines. To ensure continued access to licensed medical devices in Canada, we will be placing less priority on enforcing the summary reporting provisions at this time.

• The overall compliance, and history of compliance, with the regulations
• Industries making an effort to implement systems to comply with the summary reporting provisions

9. Guidance on clinical evidence requirements for medical devices: Overview
The guidance is for manufacturers of Class II, III and IV medical devices and regulatory representatives on the clinical evidence requirements for medical devices. Guidance is provided on:

• when clinical data/evidence is required
• the common methods to generate clinical data
• how to compare devices appropriately

10. List of Recognized Standards for Medical Devices
This document provides List of Recognized Standards for Medical Devices. It includes newly added standards, Updated versions of Standards and removed standards from the regulations.
List of recognized standard covers all the categories like Anaesthetic and respiratory, Biocompatibility, Cardiovascular, Contraception, Dental, Electromedical, General, IVD, Manufacturing, materials, Neurology, Ophthalmology, Orthopaedics, Radiology and Sterilization.

11. Updates to list of medical devices for mandatory shortage and discontinuation reporting
Health Canada has updated the list of medical devices for mandatory shortage and discontinuation reporting.
Health Canada have added Surgical staplers to the medical devices list, as these do require mandatory reporting.
Health Canada maintains and regularly updates this list, which is incorporated by reference (IBR) into the Medical Devices Regulations.
Manufacturers of Class I to IV devices and importers of Class I medical devices should check the list of medical devices regularly. As stated in sections 62.23 to 62.25 of the Regulations, you must report shortages and discontinuations of specified medical devices to Health Canada.

12. Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents
FDA is issuing this guidance to provide clarity on how we intend to reference the terms “device” and “counterfeit device” and how we intend to interpret existing references to section 201(h) of the FD&C Act, in guidance, regulatory documents, communications, and other public documents.