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The Medical Device Directives require that 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.
MedPass International is the only EU Authorized Representative (AR) staffed with regulatory experts with EU Competent Authority experience (MHRA, AFSSAPS).
MedPass International has the expertise to assume all of the responsibilities required by the EC Directives on behalf of AR Clients. This is a considerable responsibility but many contractors offering AR services see the role as little more than a mail-box activity. We see our 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.
Offering AR services since 1998 MedPass International 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 offer AR services for CE marked medical devices and those in clinical investigations.
What makes our AR service different is our ability to respond swiftly and effectively in the appropriate national language to unforeseen or out of the ordinary circumstances, all the resources of the Regulatory Affairs Department being at the disposal of AR clients as needed.
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