Guidance: COVID-19 test validation approved products
Find out which COVID-19 test products have been approved.
Find out which COVID-19 test products have been approved.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
This is a precautionary measure while the MHRA conducts the safety review.
Guidance for healthcare professionals on risk minimisation options for medicines.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Guidance on the updates to reporting forms following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
Chelonia Healthcare Limited is recalling specific batches of Paracetamol 500mg Tablets (100 pots) as a precautionary measure due to contamination following a small number of complaints of discoloured tablets within the pots.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.