Following Brexit, medical devices in Great Britain are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). 

Kinesys understands that it is vitally important that non-UK based companies retain access to the UK market. We have made the necessary arrangements to align with stated requests from the MHRA.

Compliance requires, from the 30^th of June 2023, A UKCA mark and conformity assessment from a UK Approved body for devices that are not CE marked. Non-UK manufacturers are required to appoint a UK Responsible Person who, among other tasks, is required to hold a copy of the full technical documentation for the medical devices placed on the market and to co-operate with the MHRA should the need arise. Kinesys has the necessary skills and expertise to advise organisations to allow them to obtain UKCA marking for their medical devices. 

Services we offer include:

• Regulatory Roadmaps
• Technical documentation preparation, including Clinical Evaluation Reports and Risk Management Reports to meet required standards and guidance
• Gap analysis of existing regulatory technical documentation
• Technical writing to fill any gaps in documentation, including from EU to UK requirements
• Pre-submission review of UKCA Technical Documentation
• Corrective action advice for any issues highlighted by a UK Approved Body
• UKRP Services