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Implementation of medical devices future regime

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

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
25 October 2022
Last updated:
12 March 2026
Show all updates

  1. Updated to fix broken link (https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom)

  2. Added link to press release for MHRA launches a consultation on indefinite recognition of CE-marked medical devices

  3. Updated to fix formatting issue

  4. Updated with information about the consultation on indefinite recognition of CE marking and updates about the Pre-market SI following the publication of consultation responses in July 2025.

  5. Added link to 'In Vitro Diagnostic (IVD) Medical Device roadmap', which was published 15 December 2025.

  6. Section 4 updated to include information about consultation response.

  7. Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.

  8. Published a revised 'Roadmap towards the future regulatory framework for medical devices'.

  9. Updated to include a link to the MHRA’s Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices, and to update the list of topics to be included in the 'pre-market' regulations.

  10. On 21 October 2024, the draft Post-Market Surveillance statutory instrument was laid in Parliament. The new regulations will introduce clearer and more robust requirements for PMS that improve patient safety.

  11. Updated to include intended policy on international recognition and consultation on common specifications for in vitro diagnostic medical devices (IVDs).

  12. Link to webinar 'MHRA MedTech Regulatory Reform' added to section 4.

  13. Added 'Roadmap for the Implementation of the Future Regulatory Framework for Medical Devices' and information about 'future core regulations'.

  14. Updated guidance to reflect that the the World Trade Organisation (WTO) has published the draft Post Market Surveillance Requirements Statutory Instrument.

  15. Implementation of the Future Regulations updated to include note on the reviewing of our position on the acceptance of EU MDR and EU IVDR CE certificates.

  16. This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023

  17. Published overview of timelines for placing CE marked IVDs on the Great Britain market

  18. This guidance was updated to reflect an intended extension to acceptance of CE marked medical devices on the Great Britain market beyond 30 June 2023

  19. First published.

Documents

Implementation of the future regulations

HTML

Roadmap towards the future regulatory framework for medical devices

PDF, 229 KB, 4 pages

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Statement of policy intent: international recognition of medical devices

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ANNEX A- Detailed response to WTO comments for The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Draft Regulations 2023

PDF, 166 KB, 8 pages

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Infographic: Timelines for placement of CE marked medical devices on the Great Britain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023

PDF, 185 KB, 2 pages

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Details

Overview

This information is to support you to understand and prepare for the main regulatory updates and upcoming amendments to the Medical Device Regulations 2002.

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. 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. 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.

On 21 October 2024 the draft Post-Market Surveillance Statutory Instrument was laid in Parliament.  The new regulations  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.

On 14 November 2024, the MHRA published the 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. This provides a further update on the intended timelines to implement the future medical device regulations.

On 15 December 2025, the MHRA published an In Vitro Diagnostic (IVD) Medical Device Road Map. This roadmap outlines the planned priority deliverables for the IVD medical device work programme until mid-2027.

Contact

For further information, contact our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your trade association:

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