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.