Timelines for acceptance of CE marked medical devices in Great Britain (GB)
Page summary:
Transitional arrangements and timelines for acceptance of CE marked medical device in Great Britain.
Change made:
First published.
Time updated:
10:00am, 16 February 2026
Implementation of medical devices future regime
Page summary:
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
Change made:
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.
Time updated:
10:00am, 16 February 2026
Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices
Page summary:
This consultation invites views on proposals for recognising CE marked medical devices in Great Britain.
Change made:
First published.
Time updated:
10:00am, 16 February 2026
MHRA launches a consultation on indefinite recognition of CE-marked medical devices
Page summary:
MHRA launches a consultation on indefinite recognition of CE-marked medical devices
Change made:
First published.
Time updated:
11:21am, 16 February 2026
Clinical trials for medicines: apply for authorisation in the UK
Page summary:
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Change made:
Clarified the ‘clinical trial definition’ section and removed outdated information. Updated information under ‘Applicants must submit the following’.
Time updated:
4:55pm, 18 February 2026
UK medical device testing hits record high as MHRA backs growth in brain and AI technology
Page summary:
Patients benefit from earlier access to technologies that could improve or save lives, as the MHRA approved 17 per cent more clinical investigations in 2025 compared with 2024, and launches measures to support innovation and growth.
Change made:
First published.
Time updated:
12:01am, 19 February 2026
MHRA Performance Data
Page summary:
Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function.
Change made:
Published January 2026 performance data.
Time updated:
10:21am, 20 February 2026
Register medical devices to place on the market
Page summary:
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Change made:
Changes to registration requirements for Northern Ireland effective 28 May 2026Updated Fees implementation guidance; clarification concerning fee waivers and new section for Northern Ireland feesIVDs undergoing performance evaluation; minor updates to textCoronavirus test device approval (CTDA) and registering with MHRA; minor updates to textChanges to Public register of manufacturers section; medical device brand/trade name will be displayed on PARD from 23 February 2026, and further information concerning use of GMDN®
Time updated:
1:30pm, 20 February 2026
Regulating medical devices in the UK
Page summary:
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Change made:
Updates to Regulation of medical devices in Northern Ireland.Removal of text duplicated on other guidance pages.
Time updated:
1:31pm, 20 February 2026
Regulation of medical devices in Northern Ireland
Page summary:
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
Change made:
Clarification concerning registration with MHRA of custom-made devices being placed on the NI market. See the European database on medical devices (EUDAMED) section.
Time updated:
1:31pm, 20 February 2026
