{"id":2103,"date":"2022-07-12T08:20:41","date_gmt":"2022-07-12T08:20:41","guid":{"rendered":"https:\/\/www.bioevents.net\/rmd2023\/?page_id=2103"},"modified":"2022-07-14T11:34:22","modified_gmt":"2022-07-14T11:34:22","slug":"about-erpa","status":"publish","type":"page","link":"https:\/\/rmd2023.com\/about-erpa\/","title":{"rendered":"About EAAR"},"content":{"rendered":"
<\/p>\n
What is EAAR?<\/p>\n
The concept of an Authorized Representative (AR)\u00a0is based on the legal requirements contained within these European Directives and is amplified in an official guidance document titled \u2018Authorised Representatives\u2019 and published by the European Commission as\u00a0MEDDEV 2.5\/10<\/a>.<\/p>\n 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.<\/p>\n EAAR is officially recognized by the European Commission and as such is involved in the political process surrounding medical device CE Marking in Europe.<\/p>\n *EAAR is an international non-profit association established under Belgian law as an AISBL<\/p>\n
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