Guide to the review procedure
Rules for medical research with human subjects are laid down in the Medical Research Involving Human Subjects Act (WMO). Since 26 May 2021, the Medical Device Regulation (MDR) applies to clinical investigations with medical devices. From 31 January 2022, the Clinical Trial Regulation (CTR) is applicable with new rules for research with medicinal products.
Information on the legal frameworks for medical research can be found on the pages below. The legal framework stipulates the review procedure. Which framework applies and which procedures apply depends on the type of research.