Authorized Representative Services
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  • 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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MDR and IVDR Services - The MDSS Solution!

We are always thinking about you and for that reason, MDSS has been working hard to provide the most suitable options for all manufacturers to be in compliance with the European Medical Device (MDR (EU) 2017/745) and In-Vitro Device Regulation (IVDR (EU) 2017/746).


Choose Your Best Solution!

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Importer

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.

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QMS - Safety Officer... the way to PRRC

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.

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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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MDSS GmbH

Schiffgraben 41
30175 Hannover
Germany

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