The UK left the European Union with a trade deal that requires non-UK manufacturers to appoint a UK Responsible Person for their medical devices. Kinesys offers a UK Responsible Person service that allows us to register your products with the MHRA (MHRA Account no. 022797).

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.

The UK Medical Devices Regulations 2002 (SI 2002 No 618) (UK MDR 2002) which govern medical devices in the UK, include these extra registration requirements.

We have over 15 years’ experience in the field of regulations regarding medical devices and are at the forefront of regulatory compliance post-Brexit.

Our Service includes:

• Access to individuals with expert knowledge in regulatory compliance
• Registration using Kinesys as your responsible person
• Vigilance tracking and reporting including communication with relevant interested parties
• Maintaining document files for questions arising from the MHRA
• General regulatory correspondence in the UK as required

This service conforms fully with the requirements of the MHRA guidance.