Standard: Implementation of medical devices future regime

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Medicines Healthcare Products Regulatory Agency

January 9

10:59 2024

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Implementation of the Future Regulations

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Roadmap towards the future regulatory framework for medical devices

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Overview

On 26 June 2022, the MHRA published thegovernment responseto 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 atinfo@mhra.gov.ukor 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 9 January 2024 +show all updates

9 January 2024
Added 'Roadmap for the Implementation of the Future Regulatory Framework for Medical Devices' and information about 'future core regulations'.
27 July 2023
Updated guidance to reflect that the the World Trade Organisation (WTO) has published the draft Post Market Surveillance Requirements Statutory Instrument.
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.
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
16 June 2023
Published overview of timelines for placing CE marked IVDs on the Great Britain market
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
25 October 2022
First published.