The European Authorised Representative is a European requirement for companies located outside of Europe. These companies have to appoint an EAR which will make the link with European Authorities . The EAR shall fulfil the tasks described in the article 11 of the regulation MDR 2017/745.
Choosing Ettsons EAR is choosing a dedicated company for your regulatory purposes. Ettsons offer a high level of expertise in the Regulatory Medical Device field. There will be no conflict with your commercial activities and we will keep you in compliance with the MDR2017/145.
Our advanced regulatory knowledge combined with over 25 years of experience, is an asset to support your company in any case of of discussion with the European Authorities. Let us help you stand out from the rest.
Our EAR office is located in France, the second largest market of Medical Devices in Europe. Your packaging will mention our French address.
Our Person Responsible for Regulatory Compliance will be readily available to cover requirements for your representation and keep the doors of European Market open for your Medical Device.
The process can be divided into 3 major stages:
- Analysis of your company profile and product portfolio.
- Settlement of the EAR Agreement.
- Record of your technical data and registration of your company on the EUDAMED data base.
The whole process can be treated in 2 weeks.
It is really important to consider the qualification of your EAR. Without the correct qualification your EAR can lose its accreditation in EUDAMED and your sales will be not be possible anymore until you have a new EAR.
All products are concerned by the need of representation from class I to class III Medical Devices.
For manufacturers who are not established in the European Union, the authorised representative plays a pivotal role:
- in ensuring the compliance of the devices produced by those manufacturers
- in serving as their contact person established in the Union.
Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations.