UK Rep - UK Responsible Person

Qserve as your UK Rep, the UK Responsible Person for medical devices and IVD companies.

UK Responsible Person

When is a UK Rep required?

Are you located outside of Great Britain and would you like to market your devices to the Great Britain market (England, Wales, and Scotland)? You will need to appoint a UK Responsible Person (UK Rep) that is established in the UK. The UK Responsible Person (UK Rep) must then register the devices with the UK Health Authority, the Medicines & Healthcare Product Regulatory Agency (MHRA). 

Due to Brexit, there is a new route to market in the UK, including new product marking, the UK Conformity Assessment Mark (UKCA). MHRA guidance is available, and new regulations will come into force in July 2025, according to the MHRA. The MHRA published its last update on the 28th of July, 2023, and intends to introduce legislation that will bring into force the transitional arrangements and post-market surveillance activities, as outlined in the government response on June 26th, 2022. 

 
https://www.qservegroup.com/write/Afbeeldingen1/04. Local Representation/UK RP UK Responsible Person.jpg?preset=content     

Searching for a UK Responsible Person (UK Rep)?

We would like to tell you more about the Qserve UK Rep, UK RP services.

More information

What is the main impact for manufacturers after Brexit

1. There will be new regulation in the UK, UKCA, which will be mandatory by July 2025. Until that date, there is a grace period, and the EU CE mark will be accepted.

2. Devices/IVDs that will be placed on the UK market will need to be registered with the MHRA. Manufacturers need to appoint a UK Responsible Person (UK RP, UK Rep) to perform the registration.

3. The UK RP (UK, Rep) needs to be appointed by manufacturers as soon as possible. The UK RP (UK Rep) needs to have a UK entity and address.

4. Registration deadlines depend on the classification of the devices/IVDs:

  • May 1st, 2021:  Class IIIs and Class IIb implantables, all active implantable medical devices and Annex II List A IVDs
  • September 1st, 2021: Class IIb non-implantable, all Class IIa devices, IVD List B, and Self-test IVDs
  • January 1st, 2022: Class I devices and General IVDs.

5. Until the new UK regulation (UKCA) becomes mandatory (July 2025), devices/IVDs that are in compliance with the following directives/regulations can be placed on the UK market: MDD, MDR, IVD and IVDR.

6. The name and address of the UK Responsible Person, where applicable, must be included on the product labeling or the outer packaging or the instructions for use in cases where the UKCA marking has been affixed.

7. UK Responsible Person details do not need to be included on labeling for CE-marked devices unless the device bears both the CE and UKCA markings.

For more information about the UK Medical device regulation from January 2021, click here.

Responsibilities of the UK Responsible Person

  1. Check the CE certificate (if applicable), the Declaration of Conformity (DoC), and technical documentation.
  2. Register the medical devices / IVD in the MHRA database.
  3. As UK Rep (UK RP), Qserve will act on behalf of your company with the MHRA:
    a) Responding to requests from the MHRA and providing the MHRA with information and documentation necessary to demonstrate the conformity of a device.
    b) Forward to the manufacturer any request by the MHRA for samples or access to a device,
    and ensure that the MHRA receives the samples or has been given access to the device.
    c) Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if not
    possible, mitigate the risks posed by devices.
    d) Qserve will communicate any complaints and reports received from healthcare professionals,
    patients and users about suspected incidents related to the registered devices/IVDs.
    e) Keep available 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 for inspection by the MHRA.

The advantage of engaging Qserve as UK Rep

  1. Located in London, Qserve has verified access to the MHRA database.
  2. Since Qserve is an independent party, there is no conflict of interest between Qserve and the manufacturer. However, distributors often work with several manufacturers which can create issues.
  3. A respected group of experts
    a) The UK Rep is the first point of contact for regulatory issues with MHRA. Qserve has a knowledgeable team who will understand the communication they are receiving. Distributors who are not authorized representatives may not have staff with regulatory knowledge and may not understand the relevance of the communication.
    b) As a Qserve client, you will be informed of any/all changes to UK legislation, ensuring that your business is minimally impacted.
    c) Qserve’s strengths:
     • Diverse team that supports regulatory, clinical, and quality services
     • Support with UKCA regulation
     • Global footprint, local service

More information

Qserve UK Responsible Person

UK Rep (UK RP) services

  • Check the CE certificate (if applicable), the declaration of conformity (DoC), and technical documentation.
  • Qserve will act on behalf of your company with the MHRA.
  • Register medical devices and IVDs in the MHRA database.
  • Prepare a regulatory strategy for the UKCA mark.
  • Contact Notified Body for review of technical file for UKCA where applicable.
  • Support labeling conforms to UKCA.
  • Help you with the Vigilance reporting in the MORE portal.

Engaging with Qserve

Your independent UK Rep

https://www.qservegroup.com/write/Afbeeldingen1/04. Local Representation/UK-Responsible-person.jpg?preset=content

Download Qserve UK Responsible Person leaflet

https://www.qservegroup.com/write/Afbeeldingen1/05. Market Access/EC Rep EU-Representative.jpg?preset=content
https://www.qservegroup.com/write/Afbeeldingen1/05. Market Access/US FDA Agent.jpg?preset=content
https://www.qservegroup.com/write/Afbeeldingen1/05. Market Access/NMPA China Agent.jpg?preset=content

News and Updates: