UKCA Mark Certification Consultant

UKCA Mark Certification - An Overview

Although the UK Conformity Assessment procedure has not yet been formally published, it is expected that the UKCA certification process will be comparable to that of the new MDR and IVDR standards, which encompass Clinical and Performance Evaluation Reports. For the Conformity Assessment process, all manufacturers seeking to sell medical devices in the UK market must create an in-house team or identify an external consulting team as soon as possible.

The UKCA Marking now applies to the majority of goods that formerly required CE certification. From January 1, 2023, UKCA Mark Certification will be required for all medical devices sold in the United Kingdom. To learn more about medical device regulation in the United Kingdom, please contact us.

From January 1, 2021, the UK Medical Device Regulation 2002 (SI 2002 No 618, often known as UK MDR 2002) will be in effect.

UKCA Mark Consultants

The role of consultants are:

  • Requirements Identification and Device Classification Guidance
  • Technical documentation development
  • Biological Assessment
  • Evaluation of Safety
  • Support for risk analysis
  • Clinical Assessment
  • Answering UKCA Certification Bodies’ questions and keeping technical documentation up to date

UKCA Mark Certification Bodies And Certification Timeline

The following website provides further information about UKCA authorised bodies to readers.

->List of Approved Bodies for Medical Device


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