Mission and vision

The European Association of Authorised Representatives was established in 2002 in order to accurately represent organizations that provide European Authorised Representative services to non-European manufacturers of medical devices and in-vitro diagnostic medical devices. Our purpose is also to maintain a dialogue with the European Commission, Competent Authorities, Notified Bodies and other European industry associations about the role of Authorised Representatives in the context of compliance with European medical device regulatory requirements. We are officially recognised by the European Commission and are as such involved in the political process surrounding medical device CE Marking in Europe.

The EAAR is an international non-profit association established under Belgian law as an AISBL.

Our mission

We are an alliance of European Authorised Representatives who have joined forces to promote professional conduct and competence. EAAR members possess a shared vision of enhancing the quality of European Authorised Representation and aim to provide an understanding of European Authorised Representatives’ responsibilities to other stakeholders.

Regulatory background

The concept of an Authorized Representative is based on legal requirements of the European Directives 93/42/EEC (the MDD), 98/79/EC (the IVDD) and 90/385/EEC (the AIMDD) for non-European Manufacturers.
These Directives are being phased out and replaced by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
The Authorised Representative within the European Union (EU) may assume certain responsibilities on behalf of the manufacturer if delegated by the manufacturer. The legal definitions of Manufacturer and Authorised Representative are given in the Regulations, as follows.

Manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;Article 2(32) MDR and Article 2(25) IVDR

(Article 2(30) MDR and Article 2(23) IVDR).

Authorised Representative means any natural or legal person established in within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation.

Article 2(32) MDR and Article 2(25) IVDR

More information is available from the Commission of the European Union here

EC Working Groups

The European Commission working groups addresses crucial matters within the medical devices industry. This expertise is rooted in its structure of 12 subgroups, each specialising in distinct areas and offering counsel and developing guidance within their specific field of expertise: