Update on the EU Authorised Representative & Brexit

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 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.

Featured Reading

We have compiled some of our most popular articles on the EU AR issue for you.  These articles, by our expert medical devices team, look at the issues facing companies as a result of Brexit.  Companies with an EU Authorised Representative in the UK must now look to change their representative.  The clock is ticking to the end of 2020 and the UK will be completely independent of the European Union.  Furthermore, companies need to consider the impact of the new medical device regulations on the role of the Authorised Representative.  We consider that in an article featured below.

We are continuing to keep our medical device clients up to date on developments related to this issue. We will also continue to provide updates on the Acorn Regulatory website.

What You Need To Know About the EU MDR & The Authorised Representative

Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s. There is a transition period for the implementation of the various elements of the new regulations, with MDR becoming fully operational in May 2021 the IVDR in May 2022.  Read more about MDR and the EU Authorised Representative here.

10 Responsibilities of an EU AR

The responsibilities and role of the  EUAR is now in the spotlight as a result of the UK’s decision to leave the EU.  Many companies have previously chosen EU Authorised Representatives from the UK and, as a result of the referendum, will now need to choose a new representative within the EU. In this blog post, we will look at the 10 of the main responsibilities of an EU Authorised Representative.  We also highlight some of our writing on this topic.  After all, the EUAR will be an essential role within a medical device company when the new MDR is introduced. Read more here.

Contact Us

If you would like to talk to us about our EU AR services, then please contact us on 00353 52 61 76 706, email: info@acornregulatory.com or complete the form below.