MDR - annex XV - Chapter I - Article 1
Each step in the clinical investigation, from the initial consideration of the need for and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles.
All parts of a clinical investigation should be ethical and based on ethical principles. These principles basically represent the understanding of:
– not conducting unnecessary clinical investigations on humans
– not conducting clinical investigations on minors or vulnerable groups of people
– not conducting clinical investigations against the free will of a person
Further guidance is given in the declaration of Helsinki in ISO 14155.
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