UK Post-Market Surveillance Regulations

This information is to support you to understand and prepare for the main regulatory updates and upcoming amendments to the Medical Device Regulations 2002.

On 9 January 2024, the MHRA released a roadmap towards the future regulatory framework for medical devices. This provided an update on the intended timelines to implement 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 15 December 2025, the MHRA published an In Vitro Diagnostic (IVD) Medical Device Road Map. This roadmap outlines the planned priority deliverables for the IVD medical device work programme until mid-2027.

Contact

For further information, contact our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000.

Alternatively, contact your trade association:

Updated to fix broken link (https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom)

Added link to press release for MHRA launches a consultation on indefinite recognition of CE-marked medical devices

Updated to fix formatting issue

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.

Added link to 'In Vitro Diagnostic (IVD) Medical Device roadmap', which was published 15 December 2025.

Section 4 updated to include information about consultation response.

Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.

Published a revised 'Roadmap towards the future regulatory framework for medical devices'.

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.

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.

Updated to include intended policy on international recognition and consultation on common specifications for in vitro diagnostic medical devices (IVDs).

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

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

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