MDR – Article 66 – Clinical investigations on pregnant or breastfeeding women

Article 66

Clinical investigations on pregnant or breastfeeding women

A clinical investigation on pregnant or breastfeeding women 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 clinical investigation has the potential to produce a direct
benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and
burdens involved;
(b)where research is undertaken on breastfeeding women, particular
care is taken to avoid any adverse impact on the health of the child;
(c)no incentives or financial inducements are given to the subject
except for compensation for expenses and loss of earnings directly
related to the participation in the clinical investigation.

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