MDR - Chapter VI - article 66

Original text

Expert opinion

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.

Clinical investigations on pregnant or breastfeeding women

Clinical investigations on persons in special circumstances, such as pregnant or breastfeeding women, are restricted. Therefore, a higher level of scrutiny and requirements are applied when testing medical devices on such user groups.

Clinical investigation requirements, as set out in  article 62(4), form the basic requirements on which the special requirements are added on top:

a) a direct benefit to the woman or the unborn child (or child right after being born) is given and the this benefit outweights the risk and burden involved in testing on such women.
b) when testing on breastfeeding women, all risks to the child have to be avoided evolving from any leaching, extracting or other form of excreetion into the breastmilk sourcing from the  the medical device.
c) incentives or other inducements are not allowed to be given to breastfeeding women, apart from compensation for expenses or loss of earnings directly evolving from the participation in the investigation.


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