Since the UK left the EU, the UK medical device registration landscape has changed dramatically. To place a medical device on the UK market, manufacturers have new laws, regulations, and markings that they must comply with. However, Medicines and Healthcare products Regulatory Agency (MHRA) transitional arrangements, a sequence of updates and amendments, and upcoming major changes can make it difficult for manufacturers to keep on top of the UK medical device registration landscape.
This British Healthcare Trades Association (BHTA) guidance, which has been developed in coordination with the Proprietary Association of Great Britain (PAGB) and the British In Vitro Diagnostics Association (BIVDA), is designed to make it easier for medical device manufacturers to understand the current and complex landscape. It covers current and future laws and legislation around UK medical devices, how to register medical devices for the UK market, the deadlines, CE/UKCA/UKNI marking, and more.
Click below to find out more about UK medical device regulation and CE/UKCA/UKNI marking. Alternatively, you can download the PDF version here.