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Notified and accredited bodies

Independence and neutrality

DEKRA has numerous DAkkS-accredited testing laboratories and is recognized as a Notified Body in accordance with several directives and regulations.

The experts determine competently, thoroughly and objectively whether the products meet the legal requirements and the norms and standards. DEKRA does not offer advice on the technical implementation of standard or directive requirements.

    DEKRA Certification

    DEKRA Certification GmbH is a notified body and certification body for medical devices.
    As a Notified Body with the identification number 0124, DEKRA Certification GmbH accompanies conformity assessment procedures for medical devices in accordance with Directive 93/42/EEC, Regulations (EU) 2017/745 and (EU) 2017/746 for companies that place medical devices on the market. As an accredited certification body, DEKRA Certification GmbH also certifies quality management systems in accordance with EN ISO 13485 in companies that manufacture or distribute medical devices or are part of the supply chain.