MDSS EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES MDSS CONSULTING   ENGLISH    GERMAN    CHINESE

Get a Quote from MDSS Your Authorized Representative forMedical Devices and In Vitro Diagnostic Devices

News Updates
    
HIGHLIGHTS
"The NEW CE MARKING"
Get your questions answered for the NEW REGULATION
– THE MDR/IVDR!!!

more...


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


Keep up to date!

Cosmetic Products in Europe

Latest News



EVENTS
Join us!

International
MDR Happening

December 11-12, 2018
Hannover, Germany



Meet us!

Arab Health
January 28-31, 2019
Dubai

SE-Asian Healthcare & Pharma Show
April 9-11, 2019
Kuala Lumpur






Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

Click here to
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