Diese Seite verwendet Cookies. Cookies werden zur Benutzerführung und Webanalyse verwendet und helfen dabei, diese Seite besser zu machen.     Ja, ich stimme zu.  Nein, ich wünsche mehr Informationen.
Medical devices directive (93/42/EEC)

Medical devices directive (93/42/EEC)



No matter how global market conditions change in the future, with DEKRA you’re always a step ahead. As a notified body (ID number 0124), DEKRA has access to experts in all major fields of modern medical technology.


Transparency as the new standard

In our complex world, clarity is priceless. Before every project, DEKRA tells you which steps are required for the certification process and estimates the time and costs involved. This lets you know from the very beginning what to expect.

Latest News

04 Jan 2018

Change of the procedure for the examination of Technical Documentations and Design Dossiers

The Medical Device Directive 93/42/EEC requires the examination of the technical documentation by the Notified Body for Class IIa and IIb devices as w...
13 Okt 2017

Revision of EN ISO 13485 - DEKRA Certification GmbH has been accredited

DEKRA Certification is accredited and introduces the most important changes

Contact Medical Devices

Seite Auf Deutsch

Contact us