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Full text of EU MDR (Medical Device Regulation)
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Article 53 – Involvement of notified bodies in conformity assessment procedures

  1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for conformity assessment activities related to the types of devices concerned. The manufacturer may not lodge an application in parallel with another notified body for the same conformity assessment procedure.
  2. The notified body concerned shall, by means of the electronic system referred to in Article 57, inform the other notified bodies of any manufacturer that withdraws its application prior to the notified body’s decision regarding the conformity assessment.
  3. When applying to a notified body under paragraph 1, manufacturers shall declare whether they have withdrawn an application with another notified body prior to the decision of that notified body and provide information about any previous application for the same conformity assessment that has been refused by another notified body.
  4. The notified body may require any information or data from the manufacturer, which is necessary in order to properly conduct the chosen conformity assessment procedure.
  5. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities with the highest degree of professional integrity and the requisite technical and scientific competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups with an interest in the results of those activities.


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