UK Responsible Person (UKRP) for Medical Devices

ANSWERED ON THIS PAGE:

• What does the post-Brexit UK regulatory system look like?
• Do UK companies need in-country representation in the EU?
• How can medical device companies sell in the UK following Brexit?

UK Responsible Person for medical devices post-Brexit

Brexit has significantly impacted medical device companies selling in the United Kingdom, particularly regarding in-country representation. After the UK left the EU in early 2020, medical device companies face additional certification and in-country representation requirements beyond EU CE Marking in order to market their devices in the UK. With offices in the UK and the Netherlands, Emergo by UL can help you navigate post-Brexit compliance requirements in England, Wales, Scotland and Northern Ireland.

UK aligns post-Brexit medical device regulations with EU

The UK Medicines & Healthcare products Regulatory Agency (MHRA) has indicated that post-Brexit medical device and in-vitro diagnostic (IVD) regulations will align closely with the EU Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). CE-Marked devices will initially be recognized in the UK, but manufacturers will have to obtain UK Conformity Assessment (UKCA) certification starting in July 2024.

UK medical device regulations require UKRP

In-country representation requirements in the UK have also changed. Manufacturers with no local presence in the UK must now appoint a UK Responsible Person (UKRP). Your UKRP is responsible for managing your device registration as well as any relevant importer relationships, and liaising with the MHRA on your behalf.

Impact on medical device manufacturers post-Brexit

In terms of how Brexit has affected in-country representation requirements for device manufacturers in general, the following points apply:

• EU-based manufacturers distributing their devices in the European Member States (EU27) must appoint a UKRP in order to distribute their devices in the UK.
• Non-EU-based manufacturers using an EU27-based Authorized Representative (AR) must appoint a UKRP to distribute their products in the UK.
• Non-EU-based manufacturers already using a UK-based AR must appoint an EU27-based AR to distribute their products in Europe, while retaining their existing UK in-country representative as their UKRP in order to continue marketing their devices in the UK.
• UK-based manufacturers are now legally considered non-EU manufacturers, and thus need to appoint an EU27-based AR in order to distribute their devices in the EU.

UK responsible person and authorized representative services

Emergo is uniquely positioned to help you navigate regulatory compliance in Europe as well as the UK post-Brexit. You can establish representation in the UK and the EU through our offices in Cambridge, UK and The Hague, Netherlands. Here’s how we can help:

• For UK-based companies, we can act as your EC REP.
• For EU-based companies, we can act as your UKRP, if needed.
• Perform a completeness review of key components of your Technical File and review your draft labeling.

Emergo is one of the largest European Authorized Representatives for medical device and IVD manufacturers, representing hundreds of companies worldwide. Contact us to learn more about UK and EU representation services.