Moving EU Authorised Representative: Find Out How To Move

Does your company currently have an EU Authorised Representative that is based in the United Kingdom?  If so, your company will have to consider moving EU Authorised Representative very soon to ensure that you have representation with the European Union once the UK leaves the European Union.  Acorn Regulatory can assist you in moving your EU Authorised Representative from the UK to Ireland.   The result of the December 12th, 2019 election saw the Conservative Party win an overwhelming majority, having campaigned on the slogan ‘Get Brexit Done‘.  The UK Prime Minister, Boris Johnson, led the UK out of the EU in January 2020. Now, as the UK progresses through the transitional period and to a complete break from the European Union, medical device companies need to make urgent preparations to change EU Authorised Representative.

Do I Need A New EU Authorised Representative?

  • 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.
  • So, if your current representative is based in the UK you will have to appoint a new EU Authorised Representative.

Acorn Regulatory as long-standing and experienced EU Authorised Representatives for a wide variety of devices, can help your company transition from a UK based representative to an EU based representative in Ireland.

Since the announcement of the June 23rd, 2016 referendum results, we have been helping companies changing EU Authorised Representative from the UK to Ireland.

In fact, we have a team of specialists who can help your company every step of the way.

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Get Started

To get started simply complete your details below.  It is important to let us know some details about the class of the device (I, IIa, IIb or III) or if the device is an IVD or active implantable device so that we can work on your request as quickly as possible. As soon as you complete the form below, we will send you an EU Authorised Representative checklist to ensure that we have the most relevant and up to date information so that we can assist your company.

If you would like to have an initial chat with us about changing EU Authorised Representative from the UK to Ireland, then call us today on 00353 52 61 76706 or complete your details below and we will get back to you as soon as possible.

Further Reading

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 2020 the IVDR in May 2022.  Read more about MDR and the EU Authorised Representative here.

10 Responsibilities of an EU Authorised Representative

The responsibilities and role of the EU Authorised Representative (or 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.

 

About the Author
Orla Keane
Medical Devices Manager
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance.
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Bronwyn Kelly
Senior Regulatory Affairs Advisor - Medical Devices
Bronwyn Kelly is a Senior Regulatory Affairs Advisor in our growing medical devices team. She has a wealth of experience in both device and pharmaceutical regulatory affairs and she has worked with some of the world's biggest companies in both sectors, In her current role she works with device clients on issues such as EU Authorised Representative and PRRC (Person Responsible for Regulatory Compliance) related issues.
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