February Medical Device Regulatory Updates
United Kingdom 2024
Medical Device Updates
This guidance usually provides information regarding:
✓ Certifying the medical device.
✓ Conformity marking for the device.
✓ Registration of the device within the MHRA (responsible for regulating the medical devices in the UK).
The update was regarding the fee per application for registration of a new medical device or for any changes required in a device– it has changed to £240.
Source: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
26th February 2024: Update – Guidance on the access consortium:
The MHRA forms part of the access consortium alongside the Therapeutic Goods Administration, Health Canada, the Health Sciences Authority of Singapore and Swiss-Medic.
The goal of this consortium is to:
✓ Maximise international cooperation between the partners in the consortium.
✓ Reduce duplication.
✓ Increase all participants’ agency capacity to ensure high-quality, safe, and effective therapeutic products.
The update was regarding the terms of reference of the access consortium with the revision date of November 2023.
29th February 2024: Update – Guidance on the innovative devices access pathway (IDAP):
The IDAP pilot is an initiative that allows new technologies and solutions can be brought into the NHS. The aim is to:
✓ Enable and improve patient access to innovative and transformative medical devices, achieved by, providing an integrated and enhanced regulatory and access pathway to developers.
The update on this guidance was regarding the addition of the Data Protection and Privacy information to the pilot phase page of The Innovative Devices Access Pathway (IDAP).
United States 2024
Medical Device Updates
1st February 2024: The FDA issued a final rule – quality system regulations amendments:
The aim of this final rule issuing is to:
– Align more closely with international standards.
– Modernise and harmonise the regulations.
The rule will be effective on FEBRUARY 2ND, 2026
7th February 2024: The third FDA town hall on medical device sterilisation was held
The third FDA town hall was held to:
✓ Understand the expectations from the FDA for an initial premarket submission based on the 510(k) Sterility Guidance, including the recent guidance changes, sterilisation modalities categories and what to expect in a submission.
✓ Understand the additional device and submission considerations for sterility that impact the FDA review.
21st February 2024: The medical device user fee reduced for small businesses:
A draft guidance was issued by the FDA on the 22nd of February 2024, “Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance.”
Its aim is for the FDA to incorporate in this draft the updates proposed regarding the fee for small businesses, which will then be incorporated into the final guidance “Medical Device User Fee Small Business Qualification and Certification”.
This will allow the FDA to finalise the fee for small businesses (based on the guidance draft) as these show financial hardships.
29th February 2024: The fourth FDA town hall on medical device sterilization was held
The fourth FDA town hall was held to:
✓ Start leveraging the, “When to Submit a 510(k) for a Change to an Existing Device,” guidance (also known as the “Mods“ guidance) and the, “Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision-Making Process,” guidance.
✓ Understand the use of Device Master Files (MAFs) for sterility review, the meaning of using MAFs and Sterility MAFs Pilot Programs, and the difference between the MAF Pilot and the traditional MAFs.
European Union 2024
Medical Device Updates
6th February 2024: MDCG – Procedures for the updates of the European medical device nomenclature:
This document showcases all the procedures that will be involved in the annual revision of the:
✓ THE EUROPEAN MEDICAL DEVICE NOMENCLATURE (EMDN)
✓ MEDICAL DEVICE REGULATION (MDR)
✓ IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATION (IVDR)
These will also be updated based on the practical use of the EMDN and the feedback from its users.
Source: https://health.ec.europa.eu/medical-devices-sector/latest-updates_en
6th February 2024: MDCG – Guidance on the vigilance system for ce-marked devices – DSVG 00 – device specific vigilance guidance (DSVG) template
The guidance on the vigilance system for CE-marked devices (DSVG) was updated with the aim of:
✓ Providing further guidance for vigilance reports of specific devices to the manufacturers and the relevant Competent Authority.
✓ Outlining the way to report incidents to the relevant Competent Authority.
Source: https://health.ec.europa.eu/medical-devices-sector/latest-updates_en
22nd February 2024: Second call for EU reference laboratories for high-risk in-vitro diagnostic medical devices
BACKGROUND: Previously in 2022, the European Commission launched a call for the designation of EU reference laboratories for class D devices in 8 categories. 5 of these were designated and 4 remained without being designated to a suitable laboratory due to the lack of suitable applicants.
Hence, the second call is being considered to cover the remaining 4 categories, for which, the interested laboratories have until April 30th, 2024, to express their informal interest to their Member State.
Interested laboratories must fulfil some criteria outlined in the regulation to be an EU Reference Laboratory, these are:
✓ Having highly qualified staff.
✓ Have necessary equipment.
✓ Have knowledge of the standards.
✓ Have independence.