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Notified Bodies

Independence and Neutrality

DEKRA Certification: Notified & Approved Bodies for Medical Devices.

  • DEKRA Certification B.V. (ID 0344) and DEKRA Certification GmbH (ID 0124), as Notified Bodies, conduct conformity assessments in line with Directive 93/42/EEC and EU Regulations 2017/745 & 2017/746 for companies placing medical devices on the market
  • DEKRA Certification UK Ltd is a UK Approved Body (8505) for medical devices.
  • DEKRA Certification B.V., DEKRA Certification GmbH and DEKRA Certification UK Ltd certify quality management systems according to EN ISO 13485 for manufacturers, distributors, and supply chain companies in the medical device sector.

    Important documents of DEKRA Certification B.V.:

    Declaration of Impartiality

    We apply high standards, especially to ourselves
    The DEKRA Certification B.V. top management declares the following commitment to impartiality: Our guiding principle is to fulfill and actively live the values which we look for at our customers. Only thus can we perform credibly as a service provider and role model with a customer-oriented approach. The basis for this is provided by our own management system and highest transparency internally and externally.
    With the decisions they take in their daily activity, all the employees of DEKRA, including the Management Board, executives and staff, follow the principles of impartiality, objectivity and integrity.
    - Bram Holtus, Managing Director