Updated Information Pack for Candidate EU Reference Laboratories

Regulation (EU) 2017/746 authorizes the European Commission to designate EU reference laboratories for specific devices or device categories. The Commission has released an updated information pack to support this process. Candidate laboratories must submit their applications through their respective Member States, as direct submissions to the Commission are not permitted. Only laboratories located within a Member State may be put forward.

19th Update – Common List of COVID-19 Antigen Tests

The EU has revised its common list of COVID-19 antigen tests, dividing them into two categories:

• Category A: Tests assessed through prospective clinical field studies that meet agreed performance criteria.
• A.1: Eligible rapid antigen tests
• A.2: Eligible laboratory-based antigen assays
• Category B: Tests evaluated through retrospective in vitro studies that meet the same performance criteria.
• B.1: Eligible rapid antigen tests
• B.2: Eligible laboratory-based antigen assays

List of Devices No Longer Covered by Exceptional Use Authorisations

MHRA has published a list of manufacturers and medical devices that are no longer covered by exceptional use authorisations. These authorisations are granted directly to manufacturers and normally exclude distributor sales.

Borderline Products – Determining Medical Device Status

Some products are challenging to classify and are considered “borderline” until MHRA determines their regulatory status. MHRA evaluates whether a product qualifies as a medical device, a medicine, or falls into another regulatory category.

Exceptional Use Authorisations Issued During COVID-19

MHRA has also released a list of manufacturers that received exemptions during the pandemic, including those with expired or cancelled exemptions. Listings are maintained for two months after expiration or withdrawal.

Public Consultation Outcomes – Proposed 2023 Fees

The public consultation on proposed fees for Human Medicines, Medical Devices, Compliance, and Veterinary Medicines closed on 29 October. HPRA remains committed to public health while ensuring an efficient regulatory service. Fees are reviewed annually and must support HPRA’s operating costs. The proposed fee structure will be submitted to the relevant ministries for approval.

New MDR/IVDR Regulatory Information Hub

HPRA has launched a new website section that consolidates Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) resources. Newly published and previously released guidance has been organized to make navigation easier for manufacturers, authorised representatives, importers, and distributors.

Summary Reporting Provision – Notice to Industry

Health Canada acknowledges that stakeholders are facing challenges in meeting summary reporting timelines and will temporarily deprioritize enforcement. Compliance efforts and historical adherence will be considered during this period.

Guidance on Clinical Evidence Requirements

This guidance helps manufacturers of Class II–IV medical devices understand when clinical evidence is necessary, how to generate valid data, and how to compare devices effectively.

List of Recognized Standards for Medical Devices

Health Canada has issued an updated list of recognized standards, including new additions, revisions, and removals. The standards apply across a wide range of device categories, including biocompatibility, dental, cardiovascular, IVD, neurology, orthopaedics, radiology, and sterilization.

Updates to Medical Devices List for Mandatory Shortage and Discontinuation Reporting

Health Canada has added surgical staplers to the list of devices requiring mandatory shortage and discontinuation reporting. Manufacturers of Class I–IV devices and importers of Class I devices must review this list regularly.

Referencing the Definition of “Device” and “Counterfeit Device”

FDA has issued guidance clarifying how references to “device” and “counterfeit device” should be interpreted across regulatory documents, communications, and public materials, including references to section 201(h) of the FD&C Act.

Updated List of Medical Device Testing Laboratories (MDTL)

CDSCO has published an updated list of Medical Device Testing Laboratories registered to conduct testing and evaluation on behalf of manufacturers under the Medical Device Rules, 2017.

Sixth Edition Guidance on Medical Device Labelling (MDA/GD/0026)

MDA has issued the sixth edition of its labelling guidance to support compliance with Malaysia’s Medical Device Act 2012 (Act 737) and related regulations. The document must be used alongside applicable laws.

Fourth Edition Guidance on Change Notification (MDA/GD/0020)

This guidance outlines categories of permissible changes to registered medical devices and requirements for continuing distribution following modifications.

BAHRAIN (NHRA)

Circular No. (35) 2022 – Reminder on Authorized Representative Registration

NHRA has issued a reminder to medical device importers and suppliers regarding the requirement to obtain an Authorized Representative license. Beginning January 2023, commercial activities involving medical devices or related products will be removed from company registrations lacking an NHRA license, in accordance with Circular No. 39 (2020).