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In-House Workshops
The "NEW CE" mark
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EVENTS
Meet us!

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



Join us!

RAPS Twin Cities Chapter
September 07, 2017
Minneapolis-Saint Paul, USA
(more details coming soon)

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


MDSS Workshops (MDR)

End October, 2017
East Coast, USA




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.