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:

  • Pre-Brexit regulatory check and retainer
  • Access to individuals with expert knowledge in regulatory compliance
  • Registration using QCS as your responsible person
  • Vigilance tracking and reporting including communication with relevant interested parties
  • Maintaining document files for questions arising from the MHRASecretary of State
  • General regulatory correspondence in the UK as required

This service complies fully with the requirements of The Medical Devices (Amendment etc.) (EU exit) Regulations 2019 (UK MDR 2019) clause 77

Need some help?

Email us here or speak to one of our experts today by calling:

01236 734447

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