Post-Brexit Medical Device UK Market
AF Pharma offers comprehensive support for UKCA Certification and In-Country Representation Requirements
AF Pharma, with offices in the UK and Spain, offers expert assistance in navigating medical device and IVD compliance during the Brexit transition.
The departure of the UK from the EU has had a significant impact on medical device companies operating in the United Kingdom, particularly with respect to in-country representation. To market their devices in the UK, medical device companies now face additional certification and in-country representation requirements beyond the EU CE Marking. With our presence in the UK and the EU, we are is well-equipped to guide you through the post-Brexit compliance landscape in England, Wales, Scotland, and Northern Ireland.
Regarding medical device in-country representation (UK Responsible Person) and UK Conformity Assessment (UKCA), the UK Medicines & Healthcare products Regulatory Agency (MHRA) has stated that the post-Brexit medical device and in-vitro diagnostic (IVD) regulations will closely align with the EU Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). While initially recognizing CE-Marked devices in the UK, manufacturers will be required to obtain UK Conformity Assessment (UKCA) certification starting from July 2024.
In addition, the in-country representation requirements in the UK have undergone changes. Manufacturers without a local presence in the UK must now appoint a UK Responsible Person (UKRP). This UKRP will assume responsibility for managing device registration, relevant importer relationships, and acting as a liaison with the MHRA on behalf of the manufacturer.
Regarding in-country representation requirements for device manufacturers in a post-Brexit Europe, the following points apply.
Post Brexit requirements
EU-based manufacturers distributing their devices in the European Member States (EU27) must appoint a UKRP to distribute their devices in the UK.
Non-EU-based manufacturers utilizing an EU27-based Authorized Representative (AR) must appoint a UKRP to distribute their products in the UK.
Non-EU-based manufacturers who already have 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 to continue marketing their devices in the UK.
UK-based manufacturers are now considered non-EU manufacturers from a legal standpoint and, therefore, need to appoint an EU27-based AR to distribute their devices in the EU.
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