In UK, Medicines and Healthcare products Regulatory Agency (MHRA) ire responsible for regulating the medical device market, highlighting the procedures for certification, conformity marking and registrations. It covers different rules for Great Britain, Northern Ireland, and EU markets, including the requirements for UKCA marking and CE marking, the roles of UK responsible Persons, and the details on post-market surveillance and vigilance. This guidance is essential for manufacturers and suppliers who want to legally market medical devices in these regions.
If you are a medical device manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration.
General medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028.
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In vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030.
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General medical devices including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.