COVID-19 test validation approved products
Page summary:
Find out which COVID-19 test products have been approved.
Change made:
Updated Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations spreadsheet
Time updated:
1:52pm, 23 December 2024
Orphan registered medicinal products
Page summary:
A list of authorised orphan medicinal products registered by the UK licensing authority.
Change made:
Removed SCENESSE Active substance: afamelanotide from Orphan Register and added to Expired Orphans Register
Time updated:
10:33am, 30 December 2024
Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA
Page summary:
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Change made:
Updated to reflect the changes to UK legislation implementing new arrangements for medicines following agreement of the Windsor Framework, and the European Union updates to GVP module XVI.Addendum II Updated to include new contact details.
Time updated:
12:32pm, 30 December 2024
MHRA Windsor Framework hub
Page summary:
Information on the main changes introduced by the Windsor Framework.
Change made:
Added supplementary information section
Time updated:
4:50pm, 30 December 2024
In-house manufacture of medical devices in Great Britain
Page summary:
Guidance for healthcare establishments that manufacture medical devices in-house.
Change made:
Amended to add note that guidance is currently under review.
Time updated:
11:44am, 16 December 2024
Clinical investigations guidance
Page summary:
Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Change made:
Updates to section ‘Northern Ireland’. Includes attachments for ‘flow chart’ and ‘accompanying guidance’ and revised wording underneath SAE reporting.
Time updated:
5:09pm, 17 December 2024
Make a payment to MHRA
Page summary:
How to make a payment to MHRA by credit or debit card or a bank transfer.
Change made:
AMended to update Ledger Split and Extension numbers
Time updated:
4:14pm, 19 December 2024
