According to the UK Medical Devices Regulation 2002 (SI 2002 No.618, as amended), all medical device and in vitro diagnostic (IVD) manufacturers located outside the UK that want to place a medical device (or IVD) on the Great Britain market (England, Wales and Scotland) are required to appoint a UK responsible person (UKRP).
Starting from 1 July 2024, a UK Conformity Assessment (UKCA) certification will be required by all manufacturers that want to place their medical devices or in vitro diagnostics in the Great Britain (GB; England, Wales and Scotland) market (UK MDR SI 2002 No. 618, Part II, Section 10).Â
All medical devices, including IVDs intended to be sold in the GB market should be registered in Medicines and Healthcare products Regulatory Agency (MHRA).
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