A round-up of the medical devices legislative landscape and what's in store for 2025, from Claire Burrows, partner at Brabners LLP and Thorrun Govind, solicitor at Brabners LLP, pharmacist and TV health expert. If you missed their last pieces, click here and here.

This time last year, the UK's medical device regulatory framework was undergoing significant transformation. The Medicines and Healthcare products Regulatory Agency (MHRA) had outlined a roadmap of proposed steps to enhance the safety, efficacy, and traceability of medical devices of proposed steps to enhance the safety, efficacy, and traceability of medical devices.

This roadmap included plans for new statutory instruments, consultations, and stakeholder engagements to align UK regulations with international standards while addressing specific national needs. But with the anticipated UK election, no specific timescales were included, and the change in government then caused some delays in the anticipated progress.

It's important for all those operating in the medical device supply chain, including pharmacists, to understand the current regulatory landscape and what is expected in the coming months to ensure full compliance is achieved.

Key developments

A pivotal statutory instrument was introduced in October 2024, providing manufacturers with clearer guidelines on surveillance, vigilance, and reporting requirements. This move aimed to ensure that medical devices on the UK market remained safe and performed as expected, forming a fundamental basis for ongoing regulation.

In the medical devices regulatory reform roadmap the MHRA announced plans to offer abridged approvals for certain medical devices already approved by regulatory bodies such as the US FDA, Health Canada, TGA Australia, and European authorities. Additionally, a more pragmatic approach to in vitro diagnostic (IVD) regulation was being considered, incorporating lessons from the EU IVDR and exploring flexibility in UK-specific labelling requirements. Pre-consultation meetings with patient groups began, with the formal consultation opening in mid-November.

The MHRA has been working on several fronts:

Future statutory instruments and pre-market measures

A statutory instrument planned for Parliament in 2025 will include pre-market measures to enhance patient safety and device traceability, such as Unique Device Identifiers (UDI) and Implant Cards. The timeline for this instrument becoming law depends on several factors, including responses from World Trade Organization (WTO) members, final drafting, legal checks, and parliamentary schedules.

Guidance and stakeholder involvement

A guidance working group has been established to review emerging guidance supporting these regulatory changes. By the end of 2024, an early draft of the legal text for the pre-market statutory instrument is expected to be shared with trusted advisor groups. This draft, prepared by expert government lawyers, will undergo continuous review to ensure it aligns with policy and operational needs.

Consultation results and publication

In early 2025, the results of the consultation on common specifications should be published. By Spring 2025, it is proposed that the full text of the pre-market statutory instrument will be available on the WTO website, aiming to avoid delays experienced with previous publications.

Plans for 2025

The UK is set to implement several key regulatory changes this year:

Ongoing regulatory evolution

Work has already begun to identify future regulatory evolutions, reflecting the rapidly changing technological and regulatory landscape. This includes learning from the Innovative Devices Access Pathway (IDAP) and exploring options for controlled and safe early access.

Software roadmap and digital health

By March 2025, draft guidance on digital mental health technologies and AI development and deployment are expected. The long-awaited IVD Roadmap is also being reviewed, with a revised version expected in Spring 2025.

Transition timelines and industry feedback

Industry stakeholders have emphasised the need for clarity on legislative content and reasonable compliance timelines. Emerging transition timelines are being developed to address these concerns. For Post market surveillance (PMS) rules, implementation will occur six months after ministerial approval. Transition periods for various devices and IVDs are proposed, ranging from three to five years, depending on the type of certification and regulatory requirements.

What to expect next

The UK is committed to ensuring the safety and efficacy of medical devices through clear regulations and stakeholder engagement. By addressing industry concerns and adapting to technological advancements, the regulatory framework aims to support innovation while maintaining high standards of patient safety and achieving greater alignment with the EU market.

It is hoped that the proposed changes to the regulatory framework will offer greater clarity and ease the burden on supply chains when dealing with product recalls and safety concerns relating to medical devices.