UKCA - UK Responsible Person

Qserve as your UK Responsible Person for medical devices and IVD companies

UK Responsible Person

When is a UK RP required?

Are you located outside of Great Britain and would you like to market your devices onto the Great Britain market (England, Wales and Scotland)? You will need to appoint a UK Responsible Person that is established in the UK. Manufacturers should aim to appoint their UK Responsible Persons as soon as possible, where required. The UK Responsible Person must then register relevant devices with the UK Health Authority (MHRA). 

Due to Brexit, there is a new route to market in the UK including new product marking, the UK Confirmity assessment mark (UKCA). MHRA guidance is available and new regulations will come into force in July 2024. The MHRA intends to introduce legislation by Spring 2023 that will bring into force the transitional arrangements and post market surveillance activities, as outlined in the Governments Response on June 26th, 2022. Local Representation/Quote-danielle-22.jpg?preset=content    

What is the main impact for manufacturers after the Brexit

1. There will be new regulation in the UK, UKCA, which will be mandatory by June 2023. Until that date, we have 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) to perform the registration.

3. The UK RP needs to be appointed by manufacturers as soon as possible. The UK RP 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) will be mandatory (June 2023), 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 UK RP address does not have to appear on the labelling, only when you apply for the UKCA mark.

7. Labeling does not have to change until June 2023. When the manufacturer starts with compliance to the UKCA mark, the label must change to be in compliance.

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

Searching for a UK RP?

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

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Responsibilities of the UK Responsible Person

  1. Check the CE certificate (if applicable), the declaration of confirmity (DoC) and technical documentation.
  2. Register the medical devices / IVD in the MHRA database.
  3. As UK Rep, Qserve will act on behalf of your company with the MHRA:
    a) Responding to requests from the MHRA and provide 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.
    4) Qserve will communicate any complaints and reports received from healthcare professionals,
    patients and users about suspected incidents related to the registered devices/IVDs.
    5) 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 MHRA database
  2. Since Qserve is an independent party, there is not a conflict of interest between Qserve and the manufacturer. Distributors often work with several manufacturers and this can create issues.
  3. 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 made aware of any/all changes to the 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

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