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Full text of EU MDR (Medical Device Regulation)
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EU MDR Chapter 6 Article 66

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:

  1. 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;
  2. where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child;
  3. 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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