UK Responsible Person Service EN - QCS International

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UK Responsible Person Service

Introduction

QCS International is planning to offer a UK Responsible Person Service to manufacturers of medical devices who wish to continue to supply the UK market once the UK has fully departed the EU regulatory structure on 31 December 2020.  This means that QCS would act on behalf of the manufacturer for relations with the regulating authority in the UK.

Details of the service cannot yet be finalised as we await the final outcome of withdrawal arrangements, but the pages here provide you with our current understanding.

Go to our Responsible Person Blog item for the latest.

UK Responsible person service

With the UK having departed the EU we await the outcome of negotiations on the nature of the future relationship the country will have with the single market.  The nature of this relationship is yet to be finalised but the likely outcome is that for manufacturers in the EU who wish to sell their device in the UK is that they will need a ‘Responsible Person’, with a UK address, who acts as their ‘agent’ in the country.

The Responsible Person delivers an administrative function, providing the regulating body in the UK with an address within the country to which all enquiries and questions regarding the device can be sent.  In addition, it may be that the Responsible Person assists the manufacturer to successfully register their device or devices and submits all necessary documentation and paperwork with the regulating authority on their behalf.

The only current item of regulation, 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 will be designed specific to our client requirements, but is likely to include:

  • Pre-Withdrawal regulatory check and retainer
  • Access to individuals with expert knowledge in regulatory compliance in the UK
  • 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 / Secretary of State
  • General regulatory correspondence in the UK as required

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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