Update on Medical Device Regulation

The past couple of months have been an active time with some exciting updates to the regulatory landscape for medical devices.

Below is a roundup of some of the more interesting updates and insights in relation to the changing landscape for the regulation of medical devices.

European Commission: Extension to Medical Devices Regulation

The European Commission has published a draft proposed amending act to extend the transitional provisions under the EU Medical Devices Regulation (EU MDR). The proposed amending act aims to:

• extend the transitional period for medical devices covered by a notified body certificate or manufacturer’s declaration of conformity issued before 26 May 2021 until December 2027 for higher risk devices and until December 2028 devices for medium and lower risk devices, thus giving manufacturers more time to obtain EU MDR-compliant certificates
• introduce a new transitional period for class III custom-made implantable devices until May 2026, where an application for a conformity assessment has been lodged with a notified body by the medical device manufacturer by May 2024, and a contract with a notified body signed by September 2024.

This extension to the transitional provisions aims to prevent medical device shortages in the European Economic Area and acknowledges the challenges faced by the market with the original transition deadlines in the EU MDR given the COVID-19 pandemic, limited capacity of conformity assessment notified bodies, global supply chain disruptions and limited preparedness of manufacturers to bring medical devices into conformity with the updated EU MDR.

The proposed amending act can be found here. 

The text of the proposed amending act was approved by the Council of the European Union on 26 January 2023 and is set to come into law shortly. 

A useful Q&A from the European Commission about the proposed amending act can be found here.

Life Sciences Council issues statement on medical devices regulatory reform

The Life Sciences Council issued a joint statement announcing that it has entered into a new agreement to release regulatory proposals about the delivery of the future UK HealthTech regulatory system. The advisory group has agreed that aligned proposals will be published on three priority areas:

• international recognition
• routes for innovation
• system capacity.

The MHRA will publish a comprehensive UK roadmap of activities, milestones and timelines to deliver the required regulatory infrastructure to be considered as part of the revision of the Medical Devices Regulation 2002 (SI 2002/618) (UK MDR).

The Life Sciences Council Joint Statement on Medical Devices Regulatory Reform can be found here. 

Regulatory Horizons Council publishes report on regulation of AI as a medical device

The Regulatory Horizons Council have published a report on the regulation of artificial intelligence (AI) as a medical device (AIaMD), which provides 4 key recommendations:

• The MHRA should be resourced with a long-term funding commitment to enable them to create and service a regulatory framework that is efficient, proportionate and safe, and supports the UK in being a leader in the innovation, evaluation and utilisation of AIaMD.
• A strengthening of the regulatory capacity and capability in AIaMD by addressing pre-market and post-market phases, through targeted training of regulators, other gate-keepers and key contributors across the total product life-cycle.
• The UK should aim for an AIaMD regulatory framework that is ‘legislatively light’ and maximises the role of standards and guidance and builds on existing regulations for SaMD whilst also addressing the specific challenges of AI technologies.
• Manufacturers should be required to provide evidence that they have evaluated and mitigated risks of the two major issues of (1) poor generalisability and (2) AI bias that can arise due to the use of AI.

The Regulatory Horizons Council Report can be found here.

This Regulatory Horizons Council report on regulation of AI as a medical device follows on from the Government’s response to the Regulatory Horizons Council Report on medical devices, which also produced 4 recommendations in keys areas of medical device regulation. The Government response can be found here. 

How we can help

Our team of regulatory and commercial experts regularly advise clients on all aspects of the medical devices and med tech regulatory framework, including commercialisation, manufacturing and distribution arrangements. Should you wish to discuss any issues relating to medical device regulation, please contact:

Vincent Buscemi 

Louise Brennan