According to post-Brexit regulations, medical device manufacturers based outside the UK, who wish to obtain UK market access, will need to appoint a UK Responsible Person.
Learn more about how Medaptivo can help.
The United Kingdom (UK) left the European Union (EU) on 31 January 2020 and the Brexit transition period ended on 31 December 2020.
The existing Medical Device Directive 93/42/EEC, Active Implantable Medical Device Directive 90/385/EEC and In Vitro Diagnostic Medical Device Directive continue to apply in the UK, as they are incorporated into the amended UK Medical Device Regulations (MDR) 2002. The MDR 2017/715 and the IVDR 2017/746, however, came into force post-Brexit, on 1 January 2021, so they do not automatically apply in the UK.
Under the recent Northern Ireland Protocol, NI remains in the EU’s single market for goods, which means that it will have to follow both the UK and the European systems. Therefore, different rules apply to Northern Ireland and the rest of Great Britain (England, Wales and Scotland) from 26 May 2021 (MDR) and 26 May 2022 (IVDR).
According to the amended UK MDR 2002, manufacturers who are not established in the UK but wish to sell medical devices here, are required to appoint a locally registered UK Responsible Person, who will act on behalf of the manufacturer in relation to specified obligations, as outlined in the UK legislation.
Among the UK Responsible Person’s responsibilities are registration of medical devices with MHRA and notification of UK importers to MHRA on behalf of the manufacturers.
Medaptivo can provide UK Responsible Person services and fulfil all the requirements under the new legislation via its London office.