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 RP/UK Rep) that is established in the UK. The UK RP must then register the devices with the UK Health Authority, the Medicines & Healthcare Product Regulatory Agency (MHRA). 

As the result of Brexit, the new product marking the UK Conformity Assessment (UKCA) is required in order to market devices in the UK.  

According to the MHRA new regulations will come into force in July 2025. 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.  

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What is the main impact for manufacturers after Brexit

1. A new regulation in the UK (UKCA) will become 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 RP to perform the registration.

3. The manufacturers need to appoint the legal UK-based entity as UK Rep as soon as possible. 

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


Device/IVD class

May 1st, 2021

Class IIIs and Class IIb implantables, all active implantable medical devices; 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, 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 Responsible Person name and address, where applicable, must be included on the product labelling 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 labelling 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.

As your UK Rep (UK RP), Qserve will act on behalf of your company and provide support with:

a) Communicate and respond to requests from the MHRA  
b) Provide the MHRA with information and documentation necessary to demonstrate the conformity of a device. 
c) Forward MHRA requests for samples or access to a device, and ensure that the MHRA receives the samples or has been given access to the device. 
d) Cooperate with the MHRA on any actions taken to eliminate or, if not possible, mitigate the risks posed by devices. 
e) Support your company with vigilance communication - complaints and reports received from healthcare professionals, patients and users about suspected incidents related to the registered devices/IVDs. 
f) Keep available copies of the technical documentation, declaration of conformity, and, if applicable, the relevant certificate, including any amendments and supplements for inspection by the MHRA. 

The benefits of engaging Qserve as your UK RP 

  1. Qserve's legal entity is located in London. 
  2. Our verified access to the MHRA database ensures prompt and accurate regulatory handling. 
  3. As an independent party, Qserve eliminates conflicts of interest often seen with distributors who work with multiple manufacturers. 
  4. Qserve possess the necessary regulatory expertise:
  • Our team, with over 25 years of experience, acts as your first point of contact for MHRA regulatory issues and helps to stay  updated on all UK legislation changes, ensuring minimal impact on your business.
  • Diverse team specializing in regulatory, clinical, and quality services.
  • Comprehensive support with UKCA regulation and UKCA marking.
  • Global expertise paired with personalized local service. 

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