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HIGHLIGHTS
Keep up to date!

News and Views March 2017

New Medical Device Regulation (MDR) in Europe
Read more...

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



EVENTS
Meet us!

8. Medical Device Networking Meeting
Hanover, April 27, 2017



CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

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contact us





Consulting: CE Marking

CE Mark for Medical Devices


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


Before placing medical devices (including IVD and active implantable medical devices) on the European market the manufacturer has to affix the CE mark to the products. A first step to CE marking is to determine whether the product falls under one of the relevant directives.

MDSS supports you with determining whether your device falls under one of the above mentioned directives or might in case of borderline products guide you to other regulations for example cosmetic, biocidal or medicinal (drug) product regulations.

Furthermore, MDSS can provide information and guidance for the risk classification of your device. For the following steps, which finally lead to your declaration of conformity and affixing of the CE mark, MDSS offers the following service to assist you:


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