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What’s the Difference Between a UK Importer and UK Responsible Person (UKRP)?



For medical device and IVD manufacturers selling in the UK, much has changed in the last few years. First, the obvious: the UK is no longer part of the European Union. Second, the less obvious: Brexit forced UK regulators to forge their own path and like it or not, UK MHRA is now fully calling the shots when it comes to regulatory compliance and are quickly extricating themselves from the EU regulatory scheme. Get an overview of the UK medical device regulations.


The transition has been evolutionary thus far, but one such change is the need for non-UK manufacturers to appoint a UK Responsible Person (UKRP) and a Great Britain UK importer. No doubt you landed here because you are curious about the difference between these two roles. Here’s a quick summary:

The UKRP is much the same role as the European Authorized Representative but should not be confused with the EU Person Responsible for Regulatory Compliance (PRRC). The Great Britain UK importer is a newer role that performs the same duties as the EU importer. Let’s compare the two roles.


 

MedEnvoy represents hundreds of US and EU medical device and IVD manufacturers as their UKRP and Great Britain UK Importer.

 

Comparing the UKRP to the Great Britain (UK) Importer

From the table below you can see that there are many overlapping responsibilities between the UK Responsible Person and the Great Britain UK importer. The most notable difference is that your UKRP is responsible for registering your devices with the MHRA. Whereas your importer is responsible for placing your devices on the market. That's an important distinction, because the act of “placing” devices on the market carries with it a significant amount of liability.

​BEFORE PLACING DEVICES ON THE MARKET

UK Responsible Person

Great Britain UK Importer

Responsible for devices sold in England, Scotland and Wales (Great Britain)

YES

YES

​Also responsible for compliance for devices sold in Northern Ireland

YES

NO

​Verifies that devices sold in Great Britain carry the UKCA Mark, if applicable

NO

YES

​Verifies that devices sold in Northern Ireland carry the UKNI Mark

NO

NO

​Registers manufacturer devices with UK MHRA

YES

NO

​Verifies that devices have been registered in MHRA database

NO

YES

​Name and address must be added to outer packaging or product labeling as of June 2023

YES

NO

​Ensures Declaration of Conformity, relevant certificates and technical documentation have been created and maintains a copy of them

YES

YES

​Confirms proper conformity assessment procedure has been applied

YES

YES

​Verifies that devices sold in Great Britain carry the UKCA Mark

YES

YES

​Verifies that storage and transportation requirements are met

NO

YES

​Verifies labelling, UDI and accompanying information (IFU)

YES

YES

​AFTER PLACING DEVICES ON THE MARKET

UK Responsible Person

Great Britain UK Importer

​Upon request, supply MHRA with product samples and/or information demonstrating compliance with UK regulations

YES

YES

​Maintains a register of product complaints

NO

YES

​Informs manufacturer if device poses serious risk or is not in conformity

NO

YES

Has legal liability for manufacturer compliance with UK regulations

NO

YES

What about Northern Ireland?

You may be wondering why it’s called a Great Britain importer and not a UK importer. Here’s why. After Brexit, special provisions had to be established to avoid a “hard” border crossing between Ireland (part of the EU) and Northern Ireland (part of the UK). The outcome o


f that sausage making process is that Northern Ireland follows EU medical device regulations. Because the importer is responsible for “placing devices on the market,” the Great Britain importer can only fulfill this role in England, Scotland and Wales (Great Britain). To sell in Northern Ireland you’ll need a Northern Ireland importer. That being said, the UKRP represents manufacturers selling in the entire United Kingdom, including Northern Ireland. Does your head hurt yet?



Learn More UKRP and Importer

With offices in the US and Europe, MedEnvoy is one of Europe's leading regulatory compliance representatives, exclusively serving medical device and IVD manufacturers worldwide.


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