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Implementation of medical devices future regime

The MHRA have published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 25 October 2022
• Last updated: 28 March 2024 — See all updates

Documents

Implementation of the Future Regulations

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Roadmap towards the future regulatory framework for medical devices

PDF, 363 KB, 3 pages

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Details

Overview

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 provides an update on the intended timelines to implement 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:

• Association of the British HealthTech Industries (ABHI): enquiries@abhi.org.uk
• British In Vitro Diagnostics Association (BIVDA): enquiries@bivda.org.uk
• Proprietary Association of Great Britain (PAGB): regulatory@pagb.co.uk
• The British Healthcare Trades Association (BHTA): info@bhta.com
• UK Responsible Persons Association (UKRPA): enquiries@ukrp-association.org

Published 25 October 2022
Last updated 28 March 2024 + show all updates

1. 28 March 2024

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

2. 9 January 2024

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

3. 27 July 2023

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

4. 20 July 2023

   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.

5. 1 July 2023

   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

6. 16 June 2023

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

7. 27 April 2023

   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

8. 25 October 2022

   First published.