10 Responsibilities of a 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. We look at 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.
Editor’s Note: This is one of the top five most-read articles ever on our website. We have continued to ensure that the content in this article is relevant. To assist you in your research on the issue of EU Authorised Representatives we would also like to highlight other articles. We looked at the issue of the EU Authorised Representative and how the role will change with the introduction of the MDR here.
10 Responsibilities of a European Authorised Representative:
- The EU Authorised Representative will register your device with the National Competent Authorities (often referred to as the NCA) before they are marketed.
- They will act as your primary contact point for all National Competent Authorities.
- The EU Authorised Representative maintains a current copy of your Technical File available for inspection by the European Competent Authorities.
- The designated representative will have their name, address, and contact details listed on the packaging and associated materials of the device.
- Responsible for Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities, in cooperation with you and your distributors.
- Advising your company of any changes to relevant laws that will impact the marketability of your product.
- Should a member state seek to withdraw your device from the market, the EU Authorised Representative will represent your company to the European Commission.
- Maintains reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities.
- Notifies or is notified by the Competent Authorities of serious device incidents or FSCA.
- The EU Authorised Representative will also carry out any post-market surveillance that is necessary.
There are many more responsibilities of an EU Authorised Representative that need to be carried out. We have just highlighted the 10 responsibilities above.
What Impact Will the Northern Ireland Protocol Have on Medical Device Companies?
We have written extensively about the issues of the Northern Ireland Protocol and medical device companies. You can read about it, in detail, by clicking here. You can also download a whitepaper here: Northern Ireland Protocol & Medical Devices.
Need EU Authorised Representative Advice?
Our medical device regulatory affairs consultants with companies all around the world and represent them in the EU as their authorised representatives. We can represent your company and your device in the European market. Contact us today for an initial conversation about EU Authorised Representative Services.
Furthermore, we have written extensively about the issue of EU Authorised Representatives and you can read any of the (over 20) articles that touched upon the topic by clicking here.