MHRA (Medicines and Healthcare products Regulatory Agency) is the UK government department in charge of medicines and medical devices. After the UK leaves the EU, the supervision of medical device products in its market before and after the market will be in charge of the MHRA.

It should be noted that from January 1, 2021, if you want to apply to enter the UK market, you must designate a British representative, and then complete the registration on his behalf. From July 1, 2023, medical device products sold in the UK market must have the UKCA mark. Until this date, manufacturers can use the UKCA mark on a voluntary basis, and the UK market will continue to accept the CE mark until 30 June 2023.

The UKCA mark is regarded as a declaration by the manufacturer that the product complies with all provisions of the relevant law (including those relating to safety). Products bearing the UKCA mark can be sold in the UK (England, Wales and Scotland), but are not recognised in the EU, EEA or Northern Ireland markets.