UK medical devices regulation – where are we now?

As anticipated, 2025 has proven to be a critical year in the UK’s journey towards a new medical devices regulatory regime post-Brexit (see our previous updates here and here). The Medicines and Medical Devices Act 2021 (2021 Act) conferred wide powers on the Secretary of State to introduce provisions amending or supplementing the existing rules.  While we await details of the new draft core regulations, certain changes have already been implemented. Here is a round-up of some recent highlights, which are the result of various consultations by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and which show the direction of travel: 

1. Unique Device Identification (UDI) to be introduced: Manufacturers will be required to assign a UDI to devices before they are placed on the GB market (with transitional provisions). This is designed to enhance traceability, post-market surveillance (PMS) and patient safety. 
2. UKCA marking not to be mandatory: The requirement for mandatory UKCA marking on devices or packaging will be removed once UDI is operational. There are already extended transitional arrangements allowing the continued use of the EU CE mark until 30 June 2028 or 30 June 2030 (depending on the device type and classification). Further consultation on whether to extend these transitional arrangements for the CE mark is expected later this year. 
3. International reliance framework routes to market: The UK will introduce new international reliance routes, designed to expedite access to the UK market for medical devices that have already been approved by “comparable regulators” (including in the EU and US). Products will still have to be registered with the MHRA and comply with UK regulatory obligations, and the precise recognition pathway will depend on the type of device and its risk classification. Further guidance and consultation are anticipated. 
4. Risk-based classification for in vitro diagnostic (IVD) devices: There are plans to amend the conformity assessment pathways for IVD devices, aligning them with a risk-based approach. A new classification system for IVDs, including software, will align closely with international standards. It will comprise four risk classes from A (lowest risk) to D (highest risk), with more stringent requirements for devices in higher risk classes. Further guidance is expected, in particular regarding anticipated divergence from the (stricter) EU approach to Class B devices. 
5. New UK PMS regulations now in force: In June, the new Medical Devices (Post-Market Surveillance Requirements) (Amendment) Regulations 2024 entered into force, introduced pursuant to the 2021 Act, and strengthening PMS requirements for manufacturers. They represent a significant tightening of PMS obligations, including the introduction of mandatory post-market surveillance plans and periodic safety update reports, reduced incident reporting deadlines, and new requirements to report and analyse incident trends. The MHRA has published guidance on the new rules.
6. Additional retained EU Law: In February, the government confirmed it would retain four key pieces of assimilated EU law beyond their original sunset date of 26 May 2025 until such time as they are replaced by new UK legislation. The provisions cover common technical specifications for IVD devices, the provision of electronic instructions for use, the use of tissue of animal origin in medical devices, and the designation and supervision of approved bodies for device certification. 
7. Early access pathway for innovative medical devices: In July, the MHRA published a statement of policy intent to establish a new Early Access Service for innovative medical devices designed to support the MedTech sector. It will enable time-limited, conditional access to devices that meet unmet clinical need ahead of full regulatory approval, where there is a compelling clinical rationale. It will focus initially on diagnostic devices, and will offer a bridging scheme to maintain access to devices where the clinical investigation has ended and the manufacturer is still awaiting regulatory approval. 
8. New AI Commission: In September, the government launched a new AI Commission to advise the MHRA on the development of a new regulatory framework for AI in healthcare (due next year), with a focus on MedTech. This has already resulted in recent commitments to collaborate more closely with the US with respect to MedTech regulation, including initiatives to accelerate innovation and to reduce transatlantic barriers to market access. 

Next steps: 

• We are still at a very dynamic point in UK medical device regulatory development post-Brexit; further MHRA guidance as well as draft legislation, is eagerly awaited. 
• Developments so far, however, demonstrate a clear trend for closer alignment and interoperability with the EU (and other international peers) which will be welcome for industry, alongside a commitment to sovereign flexibility and the MHRA’s intention to be a global leader in innovation. 
• It is worth also keeping an eye on EU developments in parallel – noting that the EU Commission has recently consulted on reform and simplification of the MDR and IVDR (see here), following a consultation earlier this year on whether those frameworks are effective, efficient and proportionate.