UK medical devices regulatory reform: where are we now and what’s next for 2025?

In summary: The UK MHRA’s plans for reforming the medical devices regulatory framework post-Brexit have begun to take more concrete shape, with recent developments in the form of i). new Post Market Surveillance (PMS) regulations presented before the UK Parliament in October and ii). further consultation issued by the UK Government concerning specific aspects of the new core regulations. 2025 will be a critical year, with the keystone draft “core” legislation anticipated. 

To recap, the new substantive regime is now long-awaited. The consultation to overhaul the regulatory regime governing medical devices post-Brexit was launched back in September 2021, and the Government’s detailed response was published in June 2022 (see our analysis here and here). In early 2024, the MHRA published a Roadmap setting out the milestones towards the new future regulatory framework (see our update here). 

There have been two key recent developments:

1. New post-market Surveillance (PMS) regulations laid before Parliament

In October 2024, a new PMS Statutory Instrument (SI) was laid before the UK Parliament, which was the first major update to the regulatory framework since the consultation. The MHRA’s intention with the new regulations is to introduce “clearer and more robust requirements” to improve patient safety, and to facilitate greater traceability of incidents and reporting trends. The UK Government described the PMS reforms as a “priority measure” intended to provide a foundation for patient safety ahead of the introduction of further changes. 

The new SI will amend and add to the existing PMS requirements in the UK Medical Device Regulations 2002 (UK MDR) (under powers derived from section 15(1) of the Medicines and Medical Devices Act 2021). The new rules will apply to all manufacturers wishing to place medical devices on the market in Great Britain (including both UKCA marked and CE marked medical devices). 

The new requirements (if passed in their current form) will result in more stringent PMS requirements. Some of the key changes include: 

• More detailed and prescriptive requirements for PMS systems and plans, including a requirement to detail data collection and assessment procedures for the specific device, and similar devices, throughout the lifespan of the device; 
• Enhanced serious incident reporting obligations; 
• Intended, clearer obligations to consider Field Safety Corrective Action and detailed requirements for Field Safety Notices, aimed at “better target[ing] patients and users at risk”; and 
• New data review obligations, including trend reporting resulting from incident monitoring, and periodic safety reports for certain devices. 

2. Further consultation on medical devices regulations: routes to market and in vitro diagnostics

In November 2024, the MHRA published a consultation on certain proposals concerning aspects of new proposed pre-market regulations, including routes to market for medical devices and in respect of in vitro diagnostics. The consultation remains open until 5 January 2025. 

Views are sought on four areas: 

1. The introduction of a new international reliance system to replace the current international recognition system by which CE marked devices may continue to be placed on the GB market until June 2028 or June 2030 (device dependent). This would enable swifter market access for devices that have already been approved in a comparable regulator country, including the EU, USA, Canada or Australia. This reflects a broader recent trend by the MHRA (and certain other UK regulators) towards international recognition (for example it has clear similarities to the International Recognition Procedure launched earlier this year by the MHRA for medicines). 
2. In light of new planned requirements concerning device traceability (Unique Device Recognition, or “UDI”), the possible removal of the current marking requirements for devices which undergo the UKCA conformity process. The intention would be to thereby remove a potential perceived barrier to market for UKCA-marked products. 
3. The appropriate conformity assessment procedures for the proposed new risk-based IVD classification system, designed to ensure risk-proportionate patient safety controls. Proposals would see UKCA self-declaration applying to Class A and B IVD devise, with approved body involvement required for Class C and above.  
4. A proposal to remove the current revocation date of four pieces of assimilated EU law (referred to in the UK MDR) to maintain the status quo such that they would remain part of the statutory framework for medical devices until the transition to an updated medical devices regime can take place.

Looking ahead: 

The Roadmap towards the new medical devices regulatory framework was updated on 11 December 2024. It confirms that 2025 will be a critical year in the journey towards a new medical devices regulatory regime. Some key anticipated milestones include: 

1. PMS regulations: 
   • The MHRA’s anticipated timetable would see the new regulations debated and passed into law in January 2025, then entering into force in Summer 2025 following a six-month implementation period. Previously the Roadmap had anticipated end-2024 for the new regulations to enter into force. 
   • Comprehensive guidance to support manufacturers with implementation and compliance is promised in draft in Q1 2025, with final guidance to follow once the Parliamentary process has concluded. 
2. New regulations for pre-market requirements: The MHRA envisages publication of its response to the consultation in H1 2025, with the introduction of a new SI to the UK Parliament in November or December 2025. 
3. IVD roadmap to be published between April and September 2025.
4. Some key dates in the software space, including i). guidance to be published for comment on AI development and deployment, and on ii). cybersecurity related to software as a medical device, both in Q2 2025.