General Information

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n this page, we would like to provide you with the most important information on the different aspects of entering the European market as a third country manufacturer. If you find anything amiss do not hesitate to get in touch with us… We are always happy to answer your questions and give you detailed insights.

Find out more about European Authorized Representatives…

EAR

Find out more about Free Sales Certificate (German: Bescheinigung über die Verkehrsfähigkeit)…

FSC

Find out more about the Medical Devices Directive of the European Commission…

MDD

Recent News in Regulation

  • Successor of the MDD: Medical Device Regulations (MDR) starting 2016
    Successor of the MDD: Medical Device Regulations (MDR) starting 2016

    The Medical Device Directive is set to receive a major update: The new MDR will substitute the directives 93/42/EWG for Medical Devices, as well as 90/385/EWG for active implantable medical devices. In Vitro Diagnostics will receice their own directive. Changes due to the new MDR: The MDR will combine the formerly standalone directives mentiones above starting at the end of the

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