Authorized Representative Services

Will your European Authorized Representative (EC REP) be able to cope with the new European Regulations (MDR (EU) 2017/745 & IVDR (EU) 2017/746)?

As your new EC REP, MDSS has the solution for you!

Choose Your Best Solution!

Solution 1

MDR (EU) 2017/745
IVDR (EU) 2017/746

MDSS as your EC REP

Article 11. MDR and additional services on request (e.g. Vigilance)

Solution 2

MDR (EU) 2017/745
IVDR (EU) 2017/746

Your EC REP – Gold Maintained by MDSS

For Manufacturers who have a subsidiary in the European Union

Solution 3

MDR (EU) 2017/745
IVDR (EU) 2017/746

Your EC REP – Maintained by MDSS

For Manufacturers who want to set up a subsidiary in the European Union

Specifically for Swiss companies - open up your office in the EU!

Our AR Services (Authorized Representative Services) encompass the entire range of Authorized Representative Services designed to help your business thrive in these turbulent times:

European Authorized Representative (EC REP)
CE Marking
National Registration & GMDN code
Free Sales Certificate / Certificate of Marketability
Consulting
Cosmetics

MDSS, based in Hannover since 1994, pioneered European Authorized Representation and is well known and respected with Competent Authorities, which enables us to achieve the best solutions with your interests in mind. We handle sensitive tasks with the Competent Authority with integrity and perfection.
MDSS forges powerful alliances and provides timely, comprehensive solutions for our clients´ protection, benefit and corporate endurance. We strive to provide the best representation in the ever changing maze of European Regulations.

European Authorized Representatives | AR-Services

MDSS forges powerful alliances and provides timely, comprehensive solutions for our clients´ protection, benefit and corporate endurance. We strive to provide the best representation in the ever changing maze of European Regulations.

MDSS your best address, will be synonymous with quality products and compliance with the European Medical Device requirements. Because each client is unique and different, MDSS provides a customized solution for each one.

MDSS establishes respect and mutual confidence with clients to get the best results. The combined expertise of our clients and MDSS forms alliances, which ensures success in the marketplace.

MDSS serves both the Medical Device and the In Vitro Diagnostic Medical Device industries worldwide. Our clients are successful in their local marketplace and have expanded their expertise into the European arena with MDSS as their European Authorized Representative (EC REP) and Regulatory Partner.

Authorized Representatives For

Medical Devices (MDR)
In Vitro Diagnostic Devices (IVDR)
Other European Directives & Regulations (RoHS, PPE, etc.)

CONTACT
MDSS GmbH

Schiffgraben 41
30175 Hannover
Germany

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