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 Regulation (MDR) 2017/745
- In vitro Diagnostic Medical Device Regulation (IVDR) 2017/746
- Medical Device Directive (MDD) 93/42/EEC
- In-Vitro Diagnostic Directive (IVDD) 98/79/EC
- Active Implantable Medical Devices Directive (AIMD) 90/385/EEC
The concept of an Authorized Representative (AR) is based on the legal requirements contained within these European Regulations and is amplified in an official guidance document titled “Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746” and published by the European Commission as MDCG 2022-16.
Every Authorized Representative shall also have a Person Responsible for Regulatory Compliance (PRRC). PRRC qualifications, role and responsibilities are outlined in Art.15 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 and in the MDCG 2019-7 Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC).
The European Association of Authorised Representatives (EAAR) is 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.
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 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)
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(30) MDR and Article 2(23) IVDR).
More information is available from the Commission of the European Union here.