1. Apply for the UKCA logo
Different products have different ways, such as:
General CATEGORY MD and common IVD, do not need to announce the intervention of the agency, only need to do self-declaration, but the manufacturer must do product testing and provide technical documents;
For class I sterilization and class I testing, self-declaration is required at the same time as the intervention of the notified body, and the manufacturer must do product testing and provide technical documentation.
2. MHRA registration
MHRA registration is done by registering a person responsible for MHRA registration in the UK (also known as the UK representative, such as obilam). At the time of registration, the UK government gave different grace periods for different products:
● Class IIb, CLASS III, Active Implant and IVD List A have A grace period until April 30, 2021;
● The grace period for category IIb non-implanted, Category IIa, IVD List B, self-tested IVD is until August 31, 2021;
● The grace period for Class I and ordinary IVDS is until December 31, 2021.
