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News Updates
  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
    more


  • Have MDSS, your Authorized Representative, apply for a Certificate of Marketability on your behalf! more


  • Update to IVD Directive... more

  • Update to MEDDEV Guidelines... more

  • Update to Portuguese Registration... more

  • Update to Vigilance Guideline... more

  • Italian Ministry of Health abolished 100€ fee.. more

  • Update on National Drug and Health Products Safety Agency.. more

  • New European directive
    RoHS RL 2011/65/EU
    more


  • Update Harmonized Standards

    EN 980 is back...more



  • New changes of the
    legal regulations of medical
    devices in Germany

    More...


  • Agreement on new
    medical devices regulation
    shall be reached this autumn.

    More...



  • MEDICA 2014
    Düsseldorf, Germany...more


    
HIGHLIGHTS
November 12-15, 2014

MEDICA
Hall: 16
Booth: E39
Düsseldorf, Germany





Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

Click here to
contact us





European Authorized Representatives

Authorized Representatives For:
Medical Devices (MDD), In Vitro Diagnostic Devices (IVDD), EC REP & CE Mark


MDSS the Authorized Representive located in the center of EuropeThe appointment of an Authorized Representative for the Member States for the EEA is required in the European Medical Device Directives
(Medical Device Directive 93/42/EEC, Active Implantable Medical Devices 90/385/EEC and In Vitro Diagnostic Medical Device Directive 98/79/EC).

An Authorized Representative is the main contact for the European Commission and the National Competent Authorities. Appointing MDSS as your European Representative will effectively put your company on the forefront of European Regulatory Requirements.

MDSS pioneered European 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.

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



We invite you to visit all the pages of our web site, learn about MDSS and how MDSS can be of service to you and your company. We encourage you to browse our vast stores of research materials, news, information and articles on CE Mark, Authorized Representatives, Medical Device Directives (MDD), In Vitro Diagnostic Medical Device Directive (IVDD) and Active Implantable Medical Device Directives (AIMDD) plus links to other EU and regulatory affairs Authority web sites. 

Caution: Due to the rapid changes of the European regulation, the MDSS website may not be up-to-date with its information in all areas.

Therefore, always refer to the Commission website (please click and you will be automatically directed to our link section) and/or any national website for the latest regulation news. 

You may consult our News & Views section for the most frequently asked questions. To get advice on a particular aspect please contact MDSS directly.


MDSS is a member of the European Association of Authorized Representatives and certified in accordance to ISO 13485  
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