Please note this is an extract of the original bulletin.
Register medical devices to place on the market
Page summary:
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Change made:
Changes to DORS instructions for Scenarios 1 to 4 in the Guidance on registration of medical devices with an expired or expiring CE Certificate.
Time updated:
9:25am, 9 May 2023
Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU
Page summary:
The European Parliament has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of certain device certificates
Change made:
Updated Link
Time updated: 2:03pm, 9 May 2023
Notify the MHRA about a clinical investigation for a medical device
Page summary:
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Change made:
Added Validation Checklist text and document
Time updated:
10:43am, 11 May 2023
