MaxCert - MDR Expert

MaxCert - MDR Expert Authorized Representative - EC REP service / UK Responsible Person - UK RP / PRRC service Contact us in regards to your Free Sales Certificates.

MAXCERT is a professional “Authorized Representative” (EC REP) located in Germany. Serving the In Vitro Diagnostic (IVD) and Medical Device (MD) manufacturers worldwide since 1994. Whatever you like to know about the EU Regulation concerning those products, contact us! The EC REP acts on behalf of the manufacturer as the main contact for the European Commission and the National Competent Authorities. MAXCERT specializes in the additional registration requirements imposed by member states. Vigilance and Market Surveillance are an integral part of our EC REP service. This applies for the new European CE marking regulations (MDR and IVDR) and as long as needed for our clients according to the current legislations (MDD, IVDD, AIMDD and its national transpositions).

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Braueriestraße 13
Plankstadt
69190

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+4962276512286

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KAM-EU REPRESENTATIVE

Your professional partner for the successful marketing of medical devices in Europe.

According to the European directives a European Authorized Representative has to be designated by a manufacturer of medical devices, in-vitro diagnostics, and cosmetic products that is not located within the European Community. The specific tasks of the European Authorized Representative are described in the medical device directives MDD 93/42/EEC and AIMDD 90/385/EEC, the in-vitro diagnostic directive IVDD 98/79/EC and the cosmetic regulation 1223/2009.

Why KAM-EUREP is your best choice?


  • As your European Authorized Representative KAM-EUREP acts as your legal entity towards the authorities while marketing your medical devices, active implantables, clinical studies, or cosmetic products within the European Community, dealing with the obligations of the corresponding medical device directives.