UKCA Marking for Medical Devices

DEKRA in the process of becoming a UK Approved Body

With the United Kingdom (UK) leaving the European Union (EU), changes came into force for manufacturers placing products on the UK market. As of January 1, 2021, a new conformity assessment marking scheme - called UK Conformity Assessed (UKCA) marking - was launched in Great Britain (England, Wales and Scotland) in place of the CE mark.

CE marking will still be recognized by the UK for medical products until June 30, 2023. From this date onwards, manufacturers that want to (continue to) place their products on the UK 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 is committed to continue its services to customers and has started the process to become a UK Approved Body.

All medical devices placed on the market must be registered with the regulatory authority, Medicines and Healthcare products Regulatory Agency (MHRA). MHRA will have oversight of all devices on the UK market and will implement vigilance, sampling, and reporting activities as well as managing incidents. Manufacturers located in the UK can register their products directly with MHRA. Manufacturers outside the UK will need to appoint a Responsible Person to register their products. Timelines for registration can be found here: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#registrations-in-great-britain

UKCA marking for medical devices requires a third-party assessment process by a UK Approved Body. This process is similar to that currently followed in the EU for CE marking, where the conformity assessment of devices is carried out by a designated Notified Body. However, 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 and not the EU Regulations 745/2017 (MDR) and 746/2017 (IVDR).

Once designated by MHRA as a UK 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, as far as possible.

DEKRA will keep its customers informed about the next important deadlines and timings. If customers have any specific questions or concerns, they should not hesitate to contact their usual DEKRA contact.

• DEKRA is developing a robust UKCA conformity assessment process to be delivered from our DEKRA UK legal entity when designated by MHRA (expected mid-2022) as a UK Approved Body. The process is facilitated by the extensive experience of our two European Notified Bodies and our existing UK network and infrastructure.
• DEKRA is committed to supporting its customers through the changes that have resulted from Brexit. This means providing updates on the requirements and also working on the establishment of a robust UKCA conformity assessment process that minimizes duplication of activities and disruption.