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Medical Device Regulation (MDR)
Article 64

Article 64 — Clinical investigations on incapacitated subjects

  1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a clinical investigation may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are met:
    (a)

    the informed consent of their legally designated representative has been obtained;

    (b)

    the incapacitated subjects have received the information referred to in Article 63(2) in a way that is adequate in view of their capacity to understand it;

    (c)

    the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator;

    (d)

    no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the clinical investigation;

    (e)

    the clinical investigation is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in clinical investigations on persons able to give informed consent, or by other research methods;

    (f)

    the clinical investigation relates directly to a medical condition from which the subject suffers;

    (g)

    there are scientific grounds for expecting that participation in the clinical investigation will produce a direct benefit to the incapacitated subject outweighing the risks and burdens involved.

  2. The subject shall as far as possible take part in the informed consent procedure.