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Implementation of medical devices future regime

A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition.

Documents

Roadmap towards the future regulatory framework for medical devices

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Details

Overview

On 26 June 2022, 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 provides 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, MHRA released a statement of policy intent for recognition by the UK of approvals of medical devices from international regulators. This statement sets out MHRA’s proposed policy approach. The final legal text would come into force at the same time as the future core regulations.

Contact

For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your Trade Association by emailing:

Updates to this page

Published 25 October 2022
Last updated 3 July 2024 + show all updates
  1. Updated to include intended policy on international recognition and consultation on common specifications for in vitro diagnostic medical devices (IVDs).

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

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

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

  5. 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.

  6. 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

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

  8. 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

  9. First published.

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