EU Authorized Representative – Find Out What You Need To Know As Brexit Nears
In recent months we have assisted a large number of companies in transferring their EU Authorized Representative from the UK and into another EU country. Companies with an EU Authorized Representative in the UK have been forced to appoint a new representative to act on their behalf.
In this article we look at some of our recent writing about the issue and highlight three recent pieces that have been helpful to companies.
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 (following the Covid-19 delay) and the IVDR coming into effect in May 2022.
Now is the time for those impacted by the changes to the medical devices regulatory landscape to prepare for implementation of the new regulations. In the current Directives, the legal responsibility for medical devices placed on the market lies firmly with the legal manufacturer of the device. The EUDR provides detail on the additional roles responsibilities of various Economic Operators in the medical device supply chain. This was examined in our recent article here. In this second article in our series, we look in more detail at the role of Authorized Representative required for manufacturers based outside of Europe. It was established in the Directives to act as a contact point within Europe who could act on behalf of the manufacturer. The scope of the role of Authorised Representative has been expanded under EUDR compared to previously, and details may be found in Articles 11 and 12 of Regulation (EU) 2017/745. Read the full article here.
Does your company currently have an EU Authorised Representative that is based in the United Kingdom? If so, your company will have to change EU Authorised Representative very soon to ensure that you have representation with the European Union once the UK leaves the European Union.
The UK’s impending departure from the EU will necessitate a change in designated EU Authorised Representatives for companies that are currently using a UK based authorised representative at present. This will cause considerable upheaval and disruption to companies using such a service. The consensus view that Britain will seek to leave using a hard Brexit mechanism means that there is scant hope of companies being able to maintain representation through UK representatives.
Acorn Regulatory as long standing and experienced EU Authorised Representatives for a wide variety of devices, can help your company and ensure that the transition from a UK based representative to an EU based representative is trouble free. Read the full article here.
The responsibilities and role of the EU Authorised Representative (or EC Rep) 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. Read the full article here.
If you would like to speak to us about issues relating to Acorn Regulatory acting as your EU Authorised Representative, then please contact us on 00353 52 61 76 706 or complete the web form below.