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UK Responsible Person Service

Introduction

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.

Any developments with regard to the service or changes to the regulatory framework will be noted in our blog which you can access here:

UK Responsible person service

The UK has left the European Union with a trade deal that requires non-UK manufacturers to appoint a UK Responsible Person for their medical devices, QCS offer a UK Responsible Person service, that allows us to register your products with the MHRA (MHRA Account no. 11356) .

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.

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:

  • 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 MHRA
  • General regulatory correspondence in the UK as required

This service conforms fully with the requirements of the MHRA guidance

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#responsible

Call us on +44 1236 734447 or email ukrp@qcsl.co.uk

If you wish to join our mailing list for updates to medical device regulations relevant to the UK leaving the EU then do submit your details via the link given below.

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.

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