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UK Roadmap Towards the Future Regulatory Framework for Medical Devices

This blog was originally posted on 16th January, 2024. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY DENISE MCDERMOTT, SENIOR REGULATORY COMPLIANCE SPECIALIST, COMPLIANCE & RISKS

UK Roadmap: Future Regulatory Framework for Medical Devices

On 9th January 2024, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) published a roadmap for the future regulatory framework for medical devices.

The roadmap outlines the anticipated timelines for the implementation of the UK’s future medical device regulations. It includes several proposed activities and publications, such as stakeholder discussions on core regulations, public consultation on future enhancement regulations and publication of key guidance documents for software as a medical device (SaMD).

According to the roadmap, the implementation of the future regulations will be delivered in a phased approach through several Statutory Instruments over the next two years, and it is expected that its core elements will be in place in 2025. Overall, the new framework will lead to improvements in the regulatory framework for medical devices.

Post-Market Surveillance (PMS)

Regulations surrounding post-market surveillance (PMS) is a key priority for the new regulatory framework, and stakeholder discussions are planned for early 2024. The draft Post-market Surveillance Requirements Statutory Instrument, proposed in July 2023, includes plans for strengthened PMS system requirements, enhanced serious incident reporting obligations and stricter requirements on conducting periodic reviews of PMS data.

The roadmap proposes presentation of finalized PMS regulations to Parliament in 2024, with those regulations in force by the end of the year. According to the MHRA, “the government intends for the PMS statutory instrument (SI) to be laid in the first part of 2024 and it is expected to apply towards the end of 2024”. It is intended that an accompanying guidance will also be published.

Future Core Regulations

According to the MHRA, the future core regulations will ensure several improvements across a number of key areas.

Increased regulatory scrutiny for implantable medical devices with an obligatory implant card;
Requirement for unique device identifiers (UDI);
Strengthened requirements for quality management systems and technical documentation;
Elevated classification for certain SaMD;
New requirements for exempt in-house manufactured and custom-made devices;
New requirements for clinical investigations, statement of intended purpose and a Person Qualified in Regulatory Compliance;
Clarified requirements for economic operators, manufacturers, importers and distributors;
Introduction of a framework for international recognition.

The MHRA states that it will also “Bring the essential requirements for medical devices being placed on the market in GB into greater alignment with those of the EU. This will include cybersecurity requirements for software as a medical device including for artificial intelligence.”

According to the roadmap, the MHRA plans to publish SaMD guidance documents on Good Machine Learning Practice, and AI as a Medical Device (AIaMD). The agency also intends to launch the AI-Airlock project in 2024 to expedite the development and deployment of software and AI medical devices. More information on the AI-Airlock project can be found here.

CE Marked Devices in Great Britain

Currently, the acceptance of CE marked devices in Great Britain remains unchanged.
Refer to the provided infographic for timelines for placing CE marked medical devices on the Great Britain market.
The MHRA has stated that they are reviewing their position on “acceptance of EU MDR and EU IVDR CE certificates renewed after a strengthened future regime for medical devices is in place, taking on board stakeholder feedback.”

What’s Next for the UK Roadmap for Future Regulatory Framework for Medical Devices?

Overall, the roadmap towards the future regulatory framework is subject to adjustment and any changes within the government structure may impact the timelines and plans presented. Finally, the MHRA has also expressed its intention to develop a roadmap specifically for In Vitro Diagnostic (IVD) regulations within the current year.

For comprehensive information on the implementation of the future regulatory regime for medical devices in the UK and the regulatory roadmap, visit this link, and access the complete roadmap here.

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