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Declaration of Commitment

Commitment of the top management of the notified / certification body for medical devices and in vitro diagnostic medical devices of DEKRA Certification GmbH

I commit myself, within the scopes of my assigned tasks and competencies, to
  • ensure the impartiality of the body, its top management and assessment personnel.
  • ensure that the level of the remuneration of the top-level management and assessment personnel of the body and subcontractors, involved in assessment activities do not depend on the results of the assessments.
  • ensure the status of the body as a third-party body that is independent of the client in relation to which it performs conformity assessment activities. The notified body is also independent of any other economic operator having an interest in the device as well as of any competitors of the manufacturer. This does not preclude the notified body from carrying out conformity assessment activities for competing manufacturers.
  • ensure that the body is organised and operated so as to safeguard the independence, objectivity and impartiality of its activities. The body will document and implement a structure and procedures for safeguarding impartiality and for promoting and applying the principles of impartiality throughout its organisation, personnel and assessment activities. Such procedures will provide for the identification, investigation and resolution of any case in which a conflict of interest may arise, including involvement in consultancy services in the field of devices prior to taking up employment with the body. The investigation, outcome and its resolution will be documented.
  • ensure that the notified body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks are / do not:
    • the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which they assess, nor the authorised representative of any of those parties. Such restriction does not preclude the purchase and use of assessed devices that are necessary for the operations of the notified body and the conduct of the conformity assessment, or the use of such devices for personal purposes;
    • involved in the design, manufacture or construction, marketing, installation and use, or maintenance of the devices for which they are designated, nor represent the parties engaged in those activities;
    • engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are designated;
    • offer or provide any service which may jeopardise the confidence in their independence, impartiality or objectivity. In particular, they will not offer or provide consultancy services to the manufacturer, its authorised representative, a critical supplier or a commercial competitor as regards the design, construction, marketing or maintenance of devices or processes under assessment, and
    • linked to any organisation which itself provides consultancy services as referred to in point (d). Such restriction does not preclude general training activities that are not client specific and that relate to regulation of devices or to related standards.
  • ensure that involvement in consultancy services in the field of devices prior to taking up employment with the body will be fully documented at the time of employment and potential conflicts of interest will be monitored and resolved in accordance with this Annex. Personnel who were formerly employed by a specific client, or provided consultancy services in the field of devices to that specific client prior to taking up employment with the body, will not be assigned for conformity assessment activities for that specific client or companies belonging to the same group for a period of three years.
  • ensure that the body will ensure and document that the activities of its subsidiaries or subcontractors, or of any associated body, including the activities of its owners do not affect its independence, impartiality or the objectivity of its conformity assessment activities.
  • ensure that the body will operate in accordance with a set of consistent, fair and reasonable terms and conditions, taking into account the interests of small and medium-sized enterprises as defined in Recommendation 2003/361/EC in relation to fees.
  • avoid financial interests that may impair my independence in the performance of my activities at the body for medical devices and in vitro diagnostic medical devices. This includes in particular the ownership of shares, stocks, bonds or investment certificates, and/or assets and/or liabilities, in the company to be assessed and/or certified. This also applies to financial interest of parents, fiancées, life partners, spouses or children, as far as they live in domestic community with me. Excluded from this is a participation with shares traded on the stock exchange in a listed company within the framework of investment funds.
Stuttgart, 2025-02-06
The top management of the notified body / certification body for medical devices and in vitro diagnostic medical devices of DEKRA Certification GmbH:
Dr. Rolf Krökel
(Managing Director DEKRA Certification GmbH)
Markus Kopf
(Head of the Business Area Medical Devices)
Yevgeniya Siller
(Head of the Notified Body /Certification Body for Medical Devices and IVD)