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MDSS serves clients' specific needs with changes of products and regulations.  Each client is unique and MDSS customizes the solution for each client individualy..

Welcome to the MDSS Medical Device
Directives Division

At MDSS we believe that to operate effectively within the constraints of ever changing Medical Device Industry and Medical Device Directives Standards, you need an Authorized Representative who does not just represent your company, but does so with your best Regulatory Affairs interests in mind. 

At MDSS we also believe that our dedication to our clients is the very reason why you need MDSS as your "Authorized Representative" in the European marketplace.

The links below will guide you through the papers and regulations concerning the Medical Device Directives and we hope, help give you more insight and understanding of the Medical Device Directives.

Visit our News & Info page for the latest updates and information on Authorized Representatives, MDD, IVDD,  AIMDD and other important issues

Click here for
News & Views

Authorized Representative

Your Authorized Representative is the main contact for the European Commission and the National Competent Authorities. The Manufacturer is required to provide access to the Technical Docu-mentation and must include the address of the Authorized Represen-tative with the product.

Appointing MDSS as your European Representative will effectively put your company on the forefront of European Regulatory Requirements. MDSS pioneered European Representation.

Click here to learn more about
Authorized Representatives