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
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.
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 MHRA’s proposed policy approach. The final legal text would come into force at the same time as the future core regulations.
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.
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
Updates to this page
Last updated 14 November 2024 + show all updates
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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.
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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.
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Updated to include intended policy on international recognition and consultation on common specifications for in vitro diagnostic medical devices (IVDs).
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Link to webinar 'MHRA MedTech Regulatory Reform' added to section 4.
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Added 'Roadmap for the Implementation of the Future Regulatory Framework for Medical Devices' and information about 'future core regulations'.
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Updated guidance to reflect that the the World Trade Organisation (WTO) has published the draft Post Market Surveillance Requirements Statutory Instrument.
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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.
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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
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Published overview of timelines for placing CE marked IVDs on the Great Britain market
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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
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First published.