An Authorized Representative (AR) is required for manufacturers outside the EU which do not have a legal presence in the EU. They must appoint an ‘Authorized Representative’ to act as a focal point for communication with Competent Authorities on safety issues. Under the new Medical Device Regulation which take full effect in 2020, the role and responsibilities of the Authorized Representative (AR) will increase.
MedPass International was the first EU Authorized Representative to fully comply with ISO 13485. Furthermore, our regulatory team is staffed with experts with EU Competent Authority experience.
MedPass International Authorized Representative staff has considerable experience in dealing efficiently with the complex but routine aspects of the work, such as product registrations in the various Member States. We also support companies in more difficult regulatory circumstances such Field Safety Corrective Actions and restrictions on placing on the market by Member States.
With staff across the EU, our Authorized Representative service is multilingual and can respond swiftly and effectively in the appropriate national language to unforeseen or out of the ordinary circumstances.
MedPass is a founding member of the European Association of Authorized Representatives (EAAR) and as such, actively participates in all of the Association’s endeavors to promote high quality Authorized Representative services.