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



EVENTS
Meet us!

Arab Health
January 29-01 February, 2018
Dubai
Booth #Z3.D19



Join us!

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

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10. Medical Device Networking Meeting - 
a RAPS Roadshow 
December 04, 2017
Ulm, Germany

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CONTACT

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 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