Specialized in European regulatory affairs and based in Germany, MDSS acts on behalf of its clients as European Authorized Representative (EC REP) according to the CE regulations (MDR 2017/745, IVDR 2017/746).
As Authorized Representative, MDSS is the main contact for the European Commission and the National Competent Authorities.
Certified according EN ISO 13485, MDSS provides, amongst others, support in product registration, incident reporting and recall management.
Immediately upon the implementation of the requirements, MDSS acts as UK Responsible Person and Swiss Authorized Representative (CH-REP) via our subsidiaries.
MDSS is also specialized in FDA and provides the service as U.S. Agent.
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