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Experiences delivering the UK Responsible Person service

It was interesting to see that the MHRA recently released a document listing common registration errors. Microsoft Word – Document1 (

IVDeology UKRP Ltd has now been assisting non-UK manufacturers register their products with the MHRA since January 2021 so we thought we’d share what we’ve seen ourselves over the last 17 months. 

5 Top Tips for Device Registration in the UK

  • Identify and appoint an experienced UKRP provider
  • Know your UK portfolio
  • Prepare your technical documentation
  • Check you GMDN classification
  • Plan for UKCA transition

When we engage with a manufacturer, we perform a number of due diligence checks on the manufacturer and their technical documentation. As we are effectively representing the manufacturer on the UK market it is imperative that we understand their level of compliance, identify gaps and close any before we apply to the MHRA. 

In the early days we encountered minor issues with the letter of designation, even though we had constructed our letter with the help of a medical device focussed legal team. We adjusted our checklist to ensure that the checks are made on the addresses shown and as we are quality and regulatory consultants, reviewing the necessary detail is always ensured. We will work with the manufacturer to ensure that an application is accepted first time. 

We are continually reviewing our onboarding process for the UKRP service to make it as straight forward as possible for our manufacturers. However, we must perform the appropriate due diligence on the technical documentation and certification. 

We have quality, regulatory and technical experts as part of our team supporting our customers, and we fully understand both the terminology and the identity of certificates and documentation required. 

It would seem from the MHRA document that they have encountered applicants who do not fully understand the requirements or have missed the upload piece. It does concern us that falsified certificates have been identified, we will always check the validity of the certificates provided and we’re happy to say that we have not encountered this. 

One area that we have encountered on more that one occasion is the lack of GMDN codes being provided at the initiation stage, we have to ask the manufacturers for these codes or indeed update them as they were assigned many years ago. 

Manufacturers should also perform their own due diligence when appointing an UKRP service provider, they must ensure that they will be getting the correct support and level of service. If a vigilance case is identified on the UK market, the manufacturer needs to be assured that the UKRP knows how to engage with the MHRA and will communicate the issue in the correct time scales. The manufacturer also needs to be assured that the UKRP can assist with post market reporting and may also deliver regulatory updates which may affect the ability to continue to place devices on the UK market. 

It is with a view to ensure responsible delivery of UKRP services that the British In Vitro Diagnostic Association (BIVDA) have set up a directory of service providers UK Responsible Person Directory ( This is a voluntary directory but gives the contact details of a number of responsible service providers who are confident of providing the level and detail of service manufacturers need. IVDeology UKRP Ltd are proud to have been involved with the initial set up of this directory. 

Nancy Consterdine

Director of Training & Compliance Services

For more information on UKRP, UKCA, and how we can help you achieve market access in the UK, contact us [email protected]