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The MHRA have recently published an overview of timelines for placing CE marked IVD devices on the Great Britain market. The update focuses on the transitional arrangements for CE marked IVD devices compliant with EU IVDD and EU IVDR.

For better understanding, a written guidance and an infographic of the timelines for placing CE marked IVD devices on the Great Britain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023 are also included.

The MHRA have also updated guidance on registration of certain medical devices which are reusable Class I medical devices, up-classified Class I medical devices, and/or reliant on expired/expiring CE certificates.

This information was discussed during the Regulatory Affairs Working Party held on 16 June.

If you have any questions, please contact Regulatory@bivda.org.uk

Tehelj