New UK registration requirements and UKCA mark
From 1 January 2021, there will be new MHRA registration requirements indicating how medical devices will be placed on the UK market. It is safe to say that the requirements are phased in depending on the risk class. Below there’s an indicative time frame for the specific classes:
- 4 months: Class III and Class IIb implantable, active implantable medical devices, IVD List A
- 8 months: other Class IIb, Class IIa devices, IVD List B, self-testing IVD
- 12 months: Class I devices, general IVDs
Additionally, as the MHRA is likely to lose access to current and new EU data exchange for MD, a new mark is introduced: UKCA (UK conformity assessment). The CE-marked devices will still remain compliant until June 30 2023, after which they have to be compliant with the new legislation and hold the new UKCA mark. However, new devices must be compliant to the new legislation after January 1 2021.
Northern Ireland will have a special status as EU rules will keep applying there, although it is no longer part of the EU market.