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Notified Bodies

Independence and Neutrality

DEKRA Certification GmbH and DEKRA Certification B.V. are Notified Bodies and Certification Bodies for medical devices.
As a Notified Body with the identification number 0124, DEKRA Certification GmbH, and as a Notified Body with the identification number 0344, DEKRA Certification B.V. accompany conformity assessment procedures for medical devices in accordance with Directive 93/42/EEC, Regulations (EU) 2017/745 and (EU) 2017/746 for companies placing medical devices on the market. In addition, accredited certification bodies, they certify quality management systems according to EN ISO 13485 for companies involved in the manufacturing, distribution or supply chain of medical devices.

    Important documents of DEKRA Certification GmbH: