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News and Views June 2017

News and Views May 2017 - Latest Update

In-House Workshops
The "NEW CE" mark
Book now!
to make sure you’re ready to survive and thrive

Meet us!

September 09-12, 2017
National Harbor, MD, USA
Booth #537

Join us!

RAPS Twin Cities Chapter
September 07, 2017
Minneapolis-Saint Paul, USA
(more details coming soon)

RMD 2017 Europe
06-07 October, 2017
Berlin, Germany

MDSS Workshops (MDR)

End October, 2017
East Coast, USA

Contact MDSS

Schiffgraben 41
30175 Hannover

(+49)-511-6262 8630
(+49) -511-6262 8633

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contact us

Authorized Representative Services

What is so important about having an Authorized Representative?

Authorized Reporesentatives, Medical Device Safety ServiceNon-European Medical Device manufacturers exporting to Europe must designate an Authorized Representative, that is established in the European Community, to fulfill one aspect of the requirements for CE marking.

The Authorized Representative performs certain duties under the European Medical Devices Directives and acts as a legal interface between the Medical Device manufacturer and the EU Authorities. This is why MDSS was founded.  We meet the criteria for CE marking and, more importantly, MDSS has sufficient experience in Regulatory Affairs to provide this demanding and highly `responsible´ service!

Our Mission

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.  

Our Goals

MDSS, your products´ first class 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.

Our Clients

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 Authorized Representative and Regulatory Partner.

Medical Device Directives Division [MDD]

Please click here to learn more about our MDD Division

In-Vitro Directives Division [IVDD]

Please click here to learn more about our IVDD Division

Active Implantable Medical Device Directive Division  [AIMDD]

Please click here to learn more about our AIMDD Division