13/14 October 2020
How can medical devices be 'marketed' in the UK after the transitional period? The MHRA has now published a guide on how to do this. What does it say?
The guide is entitled "Regulating medical devices from 1 January 2021, How medical devices are regulated in the UK will change after the transition period has ended". It describes how medical devices will be regulated from 1 January 2021 as well as the UK system of certification, declarations of conformity and registration of medical devices. Transition periods are also mentioned. CE marking, for example, is recognised until 30 June 2023. There will be a product marking, a UKCA (UK Conformity Assessed) mark.
Medical devices placed on the UK market from 1 January 2021 must be registered with the MHRA. However, there are transitional periods depending on the class of product. Manufacturers outside the UK must then also have a "Responsible Person" in the UK. The British implementation rules of the currently still valid EU medical device directives will remain valid after 1 January 2021.
Please also see the details in the MHRA Guide entitle "Regulating medical devices from 1 January 2021".