Roles and responsibilities of the UKRP

If you want to sell your product in other countries than your own, it is important to take into account the local regulations. Many countries require so-called “third country manufacturers” to appoint an Authorised Representative before they can sell their products in the respective country.

Because of Brexit, non-UK based IVD an MD manufacturers must appoint a UK Responsible Person.

Qarad UK Ltd. can build on Qarad’s expertise as a European Authorized Representative and on the regulatory and technical competence of the Qarad team. It can act as an independent UK Responsible Person and keep your regulatory interests separate from your supply chain. 

Role of UK Responsible person

The UK Responsible Person must:

  • Register with the electronic system set-up by the Secretary of State. 
  • Supply the Secretary of State with
    • (i) written evidence that they have been appointed as a UK Responsible Person;
    • (ii) details of the Manufacturer who has so appointed them; and
    • (iii) where the person placing the devices concerned on the market is neither the Manufacturer nor the Representative, the name(s) and address(es) of the registered place(s) of business of the person(s) placing the devices concerned on the United Kingdom market.
  • Register the devices with the electronic system set-up by the Secretary of State.
  • Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the Manufacturer.
  • Keep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements.
  • In response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device.
  • Communicate to the manufacturer any request from the Secretary of State to provide samples or access to the device and communicate to the Secretary of State whether the Manufacturer intends to comply with that request.
  • Cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
  • Inform Manufacturer of any decisions of the Secretary of State or MHRA in respect of refusal or restriction of the placing on the market or making available or putting into services of Devices.
  • Immediately inform the Manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which Representative has been appointed in accordance with Representative’s vigilance reporting procedure in place at that time.
  • Terminate the legal relationship with the Manufacturer as per Article 7 of this Agreement, and inform the Secretary of State and, if applicable, the relevant Notified Body of that termination, if the Manufacturer acts contrary to its obligations under the Medical Devices (Amendment etc.) (EU Exit) Regulations 2020.

Contact us for more information about our UKRP services