Medical Device Safety Service GmbH

MDSS GmbH is a professional “Authorized Representative” (EC REP) located in Germany. Serving the In Vitro Diagnostic (IVD) and Medical Device (MD) manufacturers worldwide since 1994.
The EC REP acts on behalf of the manufacturer as the main contact for the European Commission and the National Competent Authorities.
MDSS 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 regulations (MDR and IVDR) and to the current legislations (MDD, IVDD, AIMDD and its national transpositions).

Consulting ServicesConformity Assessments