From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.
This guidance provides information on how the UK system will operate, including:
– How devices will be certified
– How devices will be conformity marked
– The process for registering devices with the MHRA
This guidance is divided into sections on the different rules that will apply in Great Britain, Northern Ireland and the EU.
Source: MHRA.