UK Responsible Person

UK RP services for Medical Devices

As of Brexit, the Medicines and Healthcare product Regulatory Agency (MHRA) requires manufacturers who are based outside of the UK to assign a UK Responsible Person (UKRP). A UKRP is essentially an Authorised Representative for manufacturers of Medical Devices and will generally fulfil the same role. UKCA Experts, part of Certification Experts, will represent you as your UK Responsible Person (UKRP) in accordance with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). With over 25 years of experience, our team of 25+ experts will help you to obtain access to the UK market.

UK-Responsible-Person-services-Medical-Devices

UK Responsible Person Medical Devices

The UK legislations concerning Medical Devices demand that a manufacturer based outside of the UK should appoint a UK Responsible Person (UKRP) if the manufacturer wants to sell their Medical Devices on the UK market. A UKRP acts on behalf of the manufacturer and ensures that the devices being sold on the UK market comply with the UK product compliance legislations. This concerns Medical Devices that are sold either directly or via e-commerce (online), or through a fulfilment service provider.

Challenges a UKRP can solve for you

If you are familiar with an Authorised Representative for medical devices, it might be difficult to find and transition to working with a suitable UKRP with a registered business in the UK. A competent UKRP will bear many responsibilities, such as: registering your (the manufacturer’s) devices with the MHRA, verifying the conformity assessment process, ensuring the availability of technical documentation for the MHRA, handling requests from the MHRA, and cooperating with them.

How Certification Experts can help

UKCA Experts, part of Certification Experts, is registered in the UK and can therefore act as your needed UKRP. Once you have assigned us as your UKRP, part of your responsibilities as a manufacturer will be outsourced to us. We can provide you with our UKRP services and will handle the aforementioned challenges for you: we will register your devices with the MHRA, verify the conformity assessment process, ensure the availability of technical documentation for the MHRA, handle requests from the MHRA, cooperate with them and more.

UK Responsible Person Medical Devices

Authorised Representative

Trust UKCA Experts to be your UK Responsible Person

What is a UK Responsible Person?

As of Brexit, the MHRA requires manufacturers who are based outside of the UK to assign a UK Responsible Person (UKRP). A UKRP is essentially an Authorised Representative for manufacturers of Medical Devices and will generally fulfil the same role in accordance with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). They are a registered legal party based within the UK that acts as a liaison between a manufacturer outside of the UK and the MHRA. Additionally, a UK Responsible Person service must include the provision of written evidence that they have the manufacturer’s authority to act as their UK Responsible Person.

What are the responsibilities of a Responsible Person?

There are a few UK responsible person requirements, including:

  • Registering the manufacturer’s devices with the MHRA
  • Ensuring that the Declaration of Conformity (UK DoC) and other technical documentation have been drawn up
  • Verifying the conformity assessment procedure
  • Making the UK DoC and technical documentation available for the MHRA
  • Handling requests from the MHRA; providing them with samples, requested Documentation and information; and cooperating with them
  • Cooperating with the MHRA to take preventive or corrective action with the purpose of eliminating or, if that is not possible, mitigating the risks posed by devices
  • Informing the manufacturer if there are any complaints and reports from healthcare professionals, patients or users about suspected incidents related to their medical device
  • Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body, of the termination

Lastly, it is important to know that the UKRP should be mentioned by name and address on the packaging (A UK responsible person symbol has not been issued by the MHRA), user instructions, or product labelling of your Medical Device as they function as your contact point for requests or concerns about your product. If your Medical Device is both CE and UKCA marked, this is still mandatory.

Who needs a UKRP?

As already stated, UKRP services have been made mandatory by the MHRA for manufacturers based outside of the UK who want to sell their Medical Devices, all classes (including Active implantable medical devices and In Vitro Diagnostic Devices), on the UK market. A UK responsible person is also used within cosmetics but AR experts does not act as a UK cosmetics responsible person.

Choose us as your UK Responsible Person (UKRP)!

MHRA UK responsible person medical device

MHRA is an abbreviation for Medicines and Healthcare product Regulatory Agency, sponsored by the Department of Health and Social Care. They regulate medicines, medical devices and blood components for transfusion in the UK. UKCA Experts ensured their MHRA UK responsible person registration in order to register the medical devices of our client. In the UK, devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with a UK responsible person MHRA. Additionally, devices that have been CE marked under the EU MDD, EU AIMDD or EU IVDD will continue to be accepted on the UK market until 30 June 2023 if their certificates remain valid for the EU market under the transitional arrangements in the EU MDR and EU IVDR.

The MHRA has made it mandatory for manufacturers of Medical Devices who are based outside of the UK but want to sell on the UK market, to assign a UK responsible person for medical devices. This UKRP needs to be based within the UK and must be registered on the MHRA registration system, meaning you need a MHRA UK responsible person. After being registered, the UKRP will then be able to start performing their designated tasks, including registering the device with the MHRA. A UK responsible person symbol has not been issued by the MHRA.

What is the procedure for UKCA Experts to become your UKRP?

After your request for authorised representation in the UK, we will send you a quotation on the requested services. Once you have accepted the quotation, we will start the documentation review together. In order to do this, one of our Compliance Experts will send you a link to a designated SharePoint environment to upload the technical documentation of the product(s) you want to place on the UK market.
Our team of experts will review the provided documentation and determine whether it is complete and meets the regulatory requirements for your product category.
Once it has been determined that the documentation meets the regulatory requirements, you will receive the UK responsible person agreement provided by our subsidiary UKCA Experts Ltd., which contains the mandate for Authorised Representation in the UK. UKCA Experts uses a ‘UK Responsible Person agreement template’, which is in compliance with the UK Legislation, to compile the obligated mandate. After both parties have signed the agreement, UKCA Experts Ltd. is officially your UKRP.
We will then register your product(s) in the MHRA system. Once approved by the MHRA, we will forward you the Registration Confirmation Letter.

It is good to know that once the mandate has been signed, the tasks that it claims are officially assigned to the RP, not only can but should be carried out by the RP from that moment forward. The manufacturer has outsourced that part of their responsibility and should no longer execute these tasks themselves.

AR Experts also provide the following Authorised Representation services:

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Van Heek Medical

Wilma Peereboom Quality Coordinator
The cooperation with Certification Experts is satisfactory. They are decisive from the start and one of their main strengths is their excellent problem-solving skills.

Alfa Wassermann

Kurt Spiegel Vice President of Engineering
Certification Experts has been our partner for over 10 years and the relationship is outstanding. They’ve completed CE Marking, UKCA Marking, and act as our Authorized Representative. The face-to-face meetings are really important and save us a lot of time!

Choose us as your UK Responsible Person (UKRP)!