Clinical trials that include an in vitro diagnostic device
Page summary:
Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.
Change made:
Clarified documentation requirements where the device is not UKCA or CE marked, and the health institution exemption does not apply. Created publication ‘Figure 1. Application process for clinical trials including an IVD’. Updated publication ‘Clinical trials that include an in vitro diagnostic device’ with all of these changes as well. Amended ‘Details’ section to remove repetition.
Time updated:
9:00am, 12 January 2026
Declaration of Helsinki and Clinical Trial Regulations alignment
Page summary:
Information on the alignment of the amended UK clinical trial legislation with the Declaration of Helsinki, prioritising UK law where conflicts arise.
Change made:
First published.
Time updated:
9:00am, 12 January 2026
Archiving and retention of clinical trial records
Page summary:
Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.
Change made:
First published.
Time updated:
9:00am, 12 January 2026
Borderline products: how to tell if your product is a medicine
Page summary:
How the MHRA makes decisions on what is a medicinal product (borderline products).
Change made:
Updated to add Statistics table for May-October 2025
Time updated:
11:36am, 12 January 2026
MORE Submissions – user reference guide
Page summary:
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
Change made:
Updated MORE submissions guide with added guidance on the new report reassignment functionality, which allows users to reassign reports to the appropriate manufacturer/responsible person within the MORE portal.
Time updated:
1:36pm, 12 January 2026
Field Safety Notices for 05-09 January 2026
Page summary:
List of Field Safety Notices for 05-09 January 2026
Change made:
First published.
Time updated:
4:59pm, 12 January 2026
If you have any questions about the medical content in this email, contact MHRA on info@mhra.gov.uk
Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation
Page summary:
The MHRA is now setting out the next phase of reforms for 2026, aimed at helping patients access new cutting-edge treatments more quickly and boosting the UK’s competitiveness for global clinical research.
Change made:
Changed to press release
Time updated:
9:05am, 13 January 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:
Published Device Registration Fee Changes from 1 April 2026 recording
Time updated:
4:41pm, 16 January 2026
