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


  • MDSS, may support you with the process of applying for a Free Sales Certificate/Certificate of Marketability...more


    
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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!

AACC
August 01-03, 2017
San Diego, USA
Booth: #1941

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


Join us!

MDSS Workshop (IVDR)
August 04, 2017
San Diego, USA
Read more...


MDSS Workshops (MDR)

End October, 2017
East Coast, USA




CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

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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