Authorized Representative Services backed by a responsive, multilingual team of regulatory experts that are there when you need them
The Authorized Representative (AR) is a requirement for manufacturers outside the EU under the current directive. Any manufacturer that does not have a legal presence in the EU 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 to take full effect in 2020, the role and responsibilities of the Authorized Representative (AR) will increase.
MedPass International is the first EU Authorized Representative (AR) to fully comply with ISO 13485. Furthermore, our regulatory team is staffed with experts with EU Competent Authority experience.
MedPass International has the expertise to assume all of the responsibilities required by the EC Directives on behalf of Authorized Representative (AR) Clients. This is a considerable responsibility but many contractors offering Authorized Representative (AR) services see the role as little more than a mail-box activity. We see our Authorized Representative (AR) service as an important component of the overall service we offer to our clients, who are seeking comprehensive and expert assistance throughout the lifespan of their products.
MedPass International Authorized Representative (AR) 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 (AR) 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 (AR) services.