Legal framework for medical scientific research

Several laws and regulations exist for medical scientific research involving human subjects. The main laws are the Medical Research Involving Human Subjects Act (WMO), the Embryo Act, the EU Clinical Trial Regulation (CTR), the EU Medical Device Regulation (MDR) and/or the EU In Vitro Diagnostic Regulation (IVDR). There are also a number of (supplementary) laws, decrees and ministerial regulations, CCMO directives and codes of conduct which are/may (also) be applicable to medical scientific research involving human subjects, including research which does not fall under the scope of laws and regulations mentioned above.