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  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
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  • MDSS, may support you with the process of applying for a Free Sales Certificate/Certificate of Marketability...more


    
HIGHLIGHTS
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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



EVENTS
Meet us!

MEDICA
November 13-16, 2017
Düsseldorf, Germany
Booth #10B05



Join us!

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


9. Medical Device Networking Meeting - 
a RAPS Roadshow
November 30, 2017
Hannover, Germany

more...



CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

Click here to
contact us





CE Marking


Before placing medical devices, in-vitro diagnostic devices (IVD) and active implantable medical devices on the European market, the manufacturer has to affix the CE mark to the products. 

The Medical Device Directive (MDD) 93/42/EEC, the Active Implantable Medical Device Directive 90/385/EEC (AIMDD) and the In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC are three of more than 20 European directives  which define product categories requiring CE marking

All medical devices, with the exception of the risk class I, require the involvement of a so-called Notified Body. MDSS Consulting GmbH supports you with determining whether your device falls under one of the relevant directives or whether itis instead a cosmetic product, a biocidal product or a medicinal product.

Our expert team supports you from the beginning up to the successful declaration of conformity, including the affixing of the CE mark. 


OUR CONSULTING SERVICES IN OVERVIEW