The UK is no longer a member of the European Union. However, until December 31st, 2020 it will be bound by EU legislation. From January 1st, 2021 the UK will be completely outside of the European Union. Negotiations regarding a future trade deal are ongoing, while Covid-19 restrictions continue. The UK is expected to leave at the end of the year and has the option, until June 30th, to seek an extension to the December 31st, 2020 departure date. We look at the latest on the EU Authorised Representative and Brexit.
Since 2016 we have engaged with many companies that wish to move their EU Authorised Representative from the UK to Ireland. We have assisted them in moving their EU Authorised Representative from the UK to Ireland. However, there are still many companies that have not yet appointed a new representative. Our advice to them is to ‘act now’.
Companies that use UK-based Authorised Representatives will be required to have an EU-based Authorised Representative. Medical device manufacturers based outside of Europe who currently use the services of a UK-based Authorised Representative are advised to consider switching Authorised Representatives as soon as possible. It should be noted that transitioning to a new Authorised Representative involves appointing a new service provider for this purpose but also has implications for labelling, quality systems, registrations in the Member States, and Certificates of Free Sale among other documentation areas. A streamlined and efficient changeover plan should be discussed with the Authorised Representative service provider to ensure an orderly transition.
