Implementation of medical devices future regime
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Documents
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 Roadmaproadmap 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 Medicalmedical Devicesdevices Regulations:regulations: Routesroutes 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.
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Onwork 16programme Decemberuntil 2024, The Post-market Surveillance Statutory Instrument was signed into law. These regulations will come into force following a 6-month transition period on 16 June 2025.mid-2027.
Contact
For further information, contact our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000.
Alternatively, contact your Tradetrade association:
- 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
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Section 4 updated to include information about consultation response.
Update history
2026-02-16 10:00
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.
2025-12-15 16:00
Added link to ‘In Vitro Diagnostic (IVD) Medical Device roadmap’, which was published 15 December 2025.
2025-02-26 07:00
Section 4 updated to include information about consultation response.
2025-01-15 10:00
Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
2024-12-11 16:00
Published a revised ‘Roadmap towards the future regulatory framework for medical devices’.
2024-11-14 00:01
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.
2024-10-22 10:00
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.
2024-07-03 11:14
Guidance updated following laying of a statutory instrument in parliament setting out new legislation on post-market surveillance.
2024-05-21 09:00
Updated to include intended policy on international recognition and consultation on common specifications for in vitro diagnostic medical devices (IVDs).
2024-03-28 09:11
Link to webinar ‘MHRA MedTech Regulatory Reform’ added to section 4.