MHRA provides clarity on CE marking recognition for medical devices and IVDs

2nd August 2023

Yesterday, the MHRA issued a statement to clarify that the extended recognition of CE marking announced by the Department for Business and Trade does NOT apply to medical devices or IVDs.

Legislation that amends the UK MDR enables CE marked medical devices and IVDs to be placed on the market in Great Britain according to the following timelines:

• Medical devices CE marked under the EU MDD or EU AIMDD - until 30th June 2028 or certificate expiry, whichever is sooner.

• IVDs CE marked under the EU IVDD - until 30th June 2030 or certificate expiry, whichever is sooner.

• Medical devices and IVDs CE marked under the EU MDR or EU IVDR - until 30th June 2030.