The MHRA didn’t take a summer break this year, so while we were packing our suitcases, the MHRA has been packing in the device reforms. We’ve set out a rundown of what’s new for medical devices in the UK. The main takeaways are:
- New post-market surveillance rules are live: We’re seeing the MHRA is wasting no time in following up with manufacturers on serious incidents under the new rules.
- Pre-market reform is in motion: Devices approved in the US, Canada, and Australia may soon access the Great Britain market via streamlined routes. Bonus: the UKCA mark is on its way out once UDIs are implemented.
- CE mark recognition might become indefinite: There should be a consultation on this later this year, and we expect to see some enthusiastic input from industry.
- Early Access Service is coming: Innovative devices that meet unmet clinical needs (especially diagnostics) may benefit from early and conditional access to the Great Britain market.
The details
- New post-market surveillance rules: The MHRA kicked off the summer with the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR). Effective from 16 June 2025, these rules bring Great Britain closer to the EU MDR and IVDR—but they are not quite twins. Manufacturers need to run a gap analysis and adapt EU PMS policies and procedures for differences in Great Britain. Key requirements are:
- maintain a PMS System based on a PMS Plan, in order to identify preventive and corrective actions.
- regularly submit to the MHRA a PMS Report for lower-risk devices (Class I) or Periodic Safety Update Report (PSUR) for Class IIa and above.
- taking certain steps when reporting and investigating serious incidents, including field safety corrective actions (FSCA) or field safety notices (FSN).
Enforcement is already happening. We’ve seen manufacturers navigating the new MORE portal (guidance here) and parsing fresh guidance on reportable incidents – including device-specific examples like Software as a Medical Device (SaMD).
- Hello, international reliance; goodbye UKCA marking: On 22 July, the MHRA published its responses to parts of its public consultation on medical devices that ran from end of 2024 to January 2025. The MHRA responses focus on three proposals:
- International reliance: Devices that have already been authorised by regulators in the USA, Canada and Canada will benefit from three potential streamlined routes to the Great Britain market (with risk classification helping to define the appropriate route to take). The MHRA also intends to expand the scope of the scheme to include SaMD, subject to the demonstration of ‘entire equivalence’ – this is a higher standard than ‘substantial equivalence’ imposed by the FDA.
- UKCA marking: The MHRA intends to remove the requirement for UKCA marking, once Unique Device Identification (UDI) is implemented.
- Class B IVDs: Manufacturers will be able to self-assess conformity with the regulations, provided they also hold Quality Management System (QMS) certification to ISO 13485. Manufacturers may obtain QMS certification from UKAS accredited bodies, as well as International Accreditation Forum accredited certification bodies from Comprehensive and Progressive Agreement for Trans-Pacific Partnership countries.
The MHRA will continue developing pre-market legislation that amends existing UK medical device laws and addresses the above. This will be subject to World Trade Organization (WTO) notification requirements, and the UK government intends to publish the draft legislation on the WTO website later this year.
- CE marking recognition forever? The MHRA plans to consult later this year on indefinite recognition of CE-marked medical devices. The current transitional arrangements allow CE marked devices from the EU to be placed on the GB market until 30 June 2028 or 30 June 2030, depending on the device. However, the response to the MHRA’s public consultation on devices was loud and clear – industry wants continued recognition beyond 2030.
- Early Access Service for GB market and innovative devices: At July’s end, the MHRA unveiled a statement of policy intent to launch an Early Access service. The service is aimed at innovative devices that meet urgent NHS needs – especially diagnostics. Conditional, time-limited authorisations will help innovators gather real-world evidence before full approval. The service builds on learnings from the Unmet Clinical Need Authorisation (UCNA) tool piloted in the Innovative Devices Access Pathway (IDAP). Manufacturers under the scheme will still be required to monitor and report safety incidents.
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