Authorized Representative Services

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European Authorized Representative (EC REP)

European Authorized Representative for Medical Devices (MDR (EU) 2017/745) and In Vitro Diagnostic Devices (IVDR (EU) 2017/746).

The appointment of an European Authorized Representative (EC REP) for the Member States of the EEA is required in the European Medical Device Regulations, Medical Device Regulation (MDR (EU) 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746), to fulfill one aspect of the requirements for CE marking.

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CE Marking

Before placing medical devices (MD), in vitro diagnostic devices (IVD) and implantable medical devices on the European market, the manufacturer has to affix the CE mark to the products.   


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National Registration & GMDN code

Appoint MDSS to perform National Registrations on your behalf!

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




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Consulting

The consultancy team of MDSS Consulting GmbH offers many years of experience in the interpretation and implementation of regulatory requirements worldwide.  

Thanks to our consulting services, we guide your company safely though the jungle of laws, standards, directives and regulations.  

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Cosmetics

Are you a company or a manufacturer of cosmetics products or brand owner outside of the European Union intending to establish / sell products in the European market?

MDSS Cosmetics is the company you are looking for. Our team will be glad to assist you with expertise and over twenty years of experience in European Regulatory Affairs.

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