UKCA Marking for Medical Devices
Recently, changes came into force for manufacturers placing products on the United Kingdom (U.K.) market, as the U.K. left the European Union (EU). As of January 1, 2021, a new conformity assessment marking scheme — called UK Conformity Assessed (UKCA) marking — was launched in place of the CE mark.
Since June 30, 2023, manufacturers that want to place their products on the U.K. market need to comply with the new UKCA marking regulation.
All medical devices placed on the market must be registered with the MHRA. This regulatory body has oversight of all devices on the U.K. market and will implement vigilance, sampling, and reporting activities, as well as manage incidents. Manufacturers in the U.K. can register their products directly with the MHRA. Manufacturers outside the U.K. will need to appoint a U.K. Responsible Person to register their products.
UKCA marking for medical devices requires a third-party assessment process by a U.K. Approved Body. This is similar to the process currently followed in the EU for CE marking, in which the conformity assessment of devices is carried out by a designated Notified Body.