MDSS GmbH, your Authorized Representative (EC REP), offers support during the whole process of applying for a Free Sales Certificate (FSC) / Certificate of Free Sale (CFS) / Certificate of Marketability for non-European countries.   

Medical Device manufacturers established in non-member countries of the EU are obliged to designate a European Authorized Representative (EC REP).

Appoint MDSS GmbH to perform National Registrations on your behalf!

Outsourcing registration processes and delegating this obligation to MDSS GmbH helps you to keep the highest business flexibility in your distribution network. We guarantee that all information and documentation will be handled with utmost confidentiality.

MDSS provides training to build up the knowledge base needed for the implementation of the MDR. This is also recognized by the EU and via our local state of lower Saxony MDSS was given a grant for its efforts. We are proud to display the plaque on our building to advertise these measures. It specifically states support for the external training done with TUV as QMS Auditor for the medical devices industry.

Dercia Gois, Senior Consultant at MDSS, responsible for our vigilance department completed this extensive training program. Appointed as Safety Officer according to the German law and with finalizing her QMS training, she will take over the PRRC function for our clients.

More and more clients seem to have difficulties with the customers in Europe who are uncomfortable taking over importer responsibilities. MDSS was asked to import products. We are exploring the possibility whether such a service of importing your products is needed!

MDSS survey regarding import of Medical Devices.