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

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



Cosmetic Products in Europe

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EVENTS
Join us!

RAPS EU MDR / IVDR Workshop

May 16 & 17, 2018
Brussels, Belgium


MDSS Roadshow
- the “NEW CE Marking” -
‚Äč
  • May 03, 2018, Milton, MA, USA
  • July 27, 2018, Chicago, IL, USA
  • August 03, 2018, Chicago, IL, USA 



Meet us!


AACC Clinical Lab Expo
July 31-02 August, 2018
Chicago, USA
Booth #4052




Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

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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 markto 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.