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Certification of medical devices

Certification of medical devices



DEKRA Certification is a Notified Body and Certification Body for Medical Devices

As a Notified Body with the identification number 0124 we monitor conformity assessment procedures for medical devices according to MDD 93/42/EEC for companies which place medical devices on the market. Additionally as a certification body we certify quality management systems according to EN ISO 13485 for companies involved in manufacturing, distribution and all parts of the medical device delivery chain.

Your internationally recognized certified quality management system secures you approval for the European market. If you want to distribute your devices in other markets worldwide, other companies in the DEKRA Certification Group can cover all your transnational testing and auditing needs e.g. U.S.A., Canada, Brazil, Japan, Taiwan, Israel and Australia.

Latest News

16 Okt 2019

DEKRA Becomes First Notified Body in Europe for In-Vitro Diagnostics under New IVD Regulation

DEKRA has become the first certification company to be recognized as a Notified Body by the European Commission under the new EU regulation on in-vitr...
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


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