The home for the professional European Authorized Representative organizations serving Medical Device and In-Vitro Diagnostic manufacturers in accordance with the European Medical Device Directives.
Members of the European Association of Authorized Representatives (EAAR)
provide services under the following European Directives and Regulations:
- Medical Device Directive (MDD) 93/42/EEC
- In-Vitro Diagnostic Directive (IVDD) 98/79/EC
- Active Implantable Medical Devices Directive (AIMD) 90/385/EEC
- Medical Device Regulation (MDR) 2017/745
- In vitro Diagnostic Medical Device Regulation (IVDR) 2017/746
The concept of an Authorized Representative (AR) is based on the legal requirements contained within these European Directives and is amplified in an official guidance document titled ‘Authorised Representatives’ and published by the European Commission as MEDDEV 2.5/10.
The European Association of Authorised Representatives* (EAAR) 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. Its 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.
EAAR is officially recognized by the European Commission and as such is involved in the political process surrounding medical device CE Marking in Europe.
*EAAR is an international non-profit association established under Belgian law as an AISBL