Borderline products: medical devices and other products
Page summary:
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Change made:
Removal of paragraph 20. In-house manufacturing from the Borderlines page. This content is superseded on other published guidance pages.
Time updated:
9:35am, 9 June 2025
Medical devices given exceptional use authorisations
Page summary:
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Change made:
Updated to remove DEU/004/2024/002 and DEU/008/2024/001 from open list of devices given exceptional use authorisations, and adding to closed list.
Time updated:
10:20am, 9 June 2025
Manufacturer’s Online Reporting Environment (MORE)
Page summary:
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Change made:
Link added for ‘Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations’
Time updated:
12:00pm, 9 June 2025
MORE implementation
Page summary:
Guidance on the updates to reporting forms following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
Change made:
Link added for ‘Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations’
Time updated:
12:00pm, 9 June 2025
MORE Registrations – user reference guide
Page summary:
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
Change made:
Updated ‘MORE User Reference Guide’
Time updated:
12:00pm, 9 June 2025
Medical devices: post-market surveillance
Page summary:
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
Change made:
Link added for ‘Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations’
Time updated:
12:00pm, 9 June 2025
Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations
Page summary:
Documentation to support changes made to reporting Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs) to the MHRA following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
Change made:
First published.
Time updated:
12:00pm, 9 June 2025
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:
Update to reflect implementation of Article 10a Notification of interruption or discontinuation of the supply of a medical device.
Time updated:
3:04pm, 9 June 2025
COVID-19 test validation approved products
Page summary:
Find out which COVID-19 test products have been approved.
Change made:
Changed to update Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations CSV file to most recent version.
Time updated:
9:20am, 10 June 2025
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 – user reference guide’.
Time updated:
10:06am, 10 June 2025
NHS red tape blitz delivers game-changing new cancer treatment
Page summary:
Patients to benefit from new era in cancer treatment, as Government slashes red tape to unleash life-saving innovation
Change made:
First published.
Time updated:
4:09pm, 10 June 2025
MHRA Safety Roundup: May 2025
Page summary:
Summary of the latest safety advice for medicines and medical device users
Change made:
First published.
Time updated:
3:11pm, 13 June 2025
If you have any questions about the medical content in this email, contact MHRA on info@mhra.gov.uk
