UK Responsible Person
Manufacturers of medical devices who are not located within the UK must appoint a ‘UK Responsible Person’ to act on their behalf and to register their devices with the relevant UK regulatory body.
QCS is registered with the Medicines and Healthcare Regulatory Agency (MHRA) to act as a responsible person and to complete the registration process.
Failure to have an appointed responsible person will result in the product no longer being permitted in to the UK healthcare market.
UK Responsible person service
QCS understand 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 amended UK Medical Devices Regulations 2002 (SI 2002 No 618) (UK MDR 2002) which governs medical devices in the UK, will include these extra registration requirements.
QCS has 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:
This service conforms fully with the requirements of the MHRA guidance
Want to know more?
If you would like us to send you an outline quotation for your device or devices, then send us your details and we will send you a link to an online application form.
