UK Responsible Person Service
Due to the continued uncertainty regarding Brexit and the supply of medical devices to the UK market, QCS have decided to offer a UK Responsible Person service, at the request of a number of concerned current clients.
QCS understand that it is vitally important that non-UK based companies retain access to the UK market. We are making the arrangements to align with stated requests from the MHRA.
The UK MDR 2019 which will come in to force following a no-deal Brexit, states that the only lawful way to sell devices into the UK is through the use of a UK responsible person (clause 77).
Our UK responsible Person Scheme is headed by our Medical Device Expert, Dr Edward Staunton. 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:
This service complies fully with the requirements of The Medical Devices (Amendment etc.) (EU exit) Regulations 2019 (UK MDR 2019) clause 77