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UKCA Marking for Medical Devices

DEKRA in the Process of Becoming a U.K. Approved Body

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.

The CE mark will still be recognized by the U.K. for medical products until June 30, 2023. From this date forward, manufacturers that want to place their products on the U.K. market need to comply with the new UKCA marking regulation. DEKRA will be able to support its customers with these new services after designation by the Medicines and Healthcare products Regulatory Agency (MHRA). DEKRA has begun the process to become an approved body, and designation is expected in mid-2022.
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. However, the MHRA has confirmed that until June 30, 2023, UKCA marking will be based on the MDD 93/42/EEC, IVD 98/79/EC, and AIMD 90/385/EEC Directives, not EU Regulations 745/2017 (MDR) and 746/2017 (IVDR).
Once designated by the MHRA as a U.K. Approved Body, DEKRA will align the UKCA marking conformity assessment activities to the existing cycle of CE marking activities and integrate them into the certification activities already scheduled.
DEKRA is committed to supporting its customers through the changes that have resulted from Brexit. This includes providing updates on the requirements, as well as establishing a robust UKCA conformity assessment process that minimizes duplication of activities and disruption.