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?
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.
Medical device in-country representation (UK Responsible Person) and UK Conformity Assessment (UKCA)
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 2023.
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.
Medical device authorized representation (EC REP) in post-Brexit Europe
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.