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. Many changes have led to misunderstanding on the difference between a UK Importer and Responsible Person.
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 a UK Importer and Responsible Person. 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.
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.
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 of 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?
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