Implementation of medical devices future regime
Source: gov.uk (2025-02-26)

Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.

Overview

This information is to help you understand and prepare for the main regulatory changes that the Post-Market Surveillance Statutory Instrument (https://statutoryinstruments.parliament.uk/instrument/yfSlbV0P) will introduce. The new regulations will introduce clearer and more robust requirements for post-market surveillance (PMS) that improve patient safety.

The Post-market Surveillance Statutory Instrument was signed into law on 16 December 2024.

How the regulations were developed

On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom (https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom). The response outlined the intended regulatory reform including the transitional arrangements for CE marked devices placed on the Great Britain market which were put in place in 2023.

On 9 January 2024, the MHRA released a roadmap towards the future regulatory framework for medical devices. This provided an update on the intended timelines to implement the future core regulations.

On 21 May 2024, following on from stakeholder discussions throughout the first quarter of 2024, the MHRA released a statement of policy intent for recognition by the UK of approvals of medical devices from international regulators (https://assets.publishing.service.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices?preview=8000453). This statement sets out the MHRA proposed policy approach. The final legal text would come into force at the same time as the future core regulations.

The draft Post-Market Surveillance Statutory Instrument was laid in Parliament on 21 October 2024.

On 14 November 2024, the MHRA published the Consultation on medical devices regulations: routes to market and in vitro diagnostic devices (https://www.gov.uk/government/consultations/consultation-on-medical-devices-regulations-routes-to-market-and-in-vitro-diagnostic-devices). The results of this consultation will inform legislative updates to the regulatory framework.

On 11 December 2024, the MHRA published a revised Roadmap towards the future regulatory framework for medical devices (https://assets.publishing.service.gov.uk/media/6759a8827e419d6e07ce2b21/Med_Tech_Regulatory_Roadmap_V2_December_2024.pdf). This provides a further update on the intended timelines to implement the future medical device regulations.

Contact

For further information, contact our Customer Services Centre at xxx@xxx.xx (mailto:xxx@xxx.xx) or call xx-xxxx-xxxx. Alternatively, contact your trade association:
- Association of the British HealthTech Industries (ABHI): xxx@xxx.xx (mailto:xxx@xxx.xx)
- British In Vitro Diagnostics Association (BIVDA): xxx@xxx.xx (mailto:xxx@xxx.xx)
- Proprietary Association of Great Britain (PAGB): xxx@xxx.xx (mailto:xxx@xxx.xx)
- The British Healthcare Trades Association (BHTA): xxx@xxx.xx (mailto:xxx@xxx.xx)
- UK Responsible Persons Association (UKRPA): xxx@xxx.xx (mailto:xxx@xxx.xx)