UKCA Requirements for Medical Device Manufacturers

Following the UK’s exit from the European Union (EU), the requirements for medical devices is laid out in legislation, the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). The UK MDR covers the rules for devices being placed on the market in the UK (Great Britain, GB and Northern Ireland, NI).

There’s a divergence in the rule between NI and GB (England, Scotland and Wales). The UKCA mark is required in GB and UKNI mark required in NI. The CE mark is still a requirement in NI. CE marked devices can continue to be placed on the market in GB until 30 June 2023. After this, UKCA mark becomes mandatory in GB.

This webinar provides general guidance on UKCA marking and the general requirements for manufacturers wishing to place their products in the UK market.

Key Points Covered

• General guidance on the UKCA conformity assessment process
• Device registration with MHRA
• UK Responsible Person
• Rules in Great Britain vs Northern Ireland
• CE marked devices in the UK
• Labelling

About the Speaker

Dr. Itoro Udofia
MHS Director at TÜV SÜD (UK)

Itoro was formerly the Head of Notified Body at UL International (UK), and spent over nine years at BSI where he held several positions (including, Product Specialist, Global Head of Orthopaedics and Dentals Devices, and Head of Operations and Training). Itoro has over eighteen years of experience working with orthopaedics devices.