Medical Devices Decree and Active Implantable Devices Decree

Research with medical devices is usually covered by the WMO. The supplementary legal frameworks for research like this are laid down in the Medical Devices Decree and Active Implantable Devices Decree. These decrees also stipulate that manufacturers must submit a positive opinion from an accredited MREC to the Health and Youth Care Inspectorate (IGJ) before the research starts. You can find more information on the Research with a medical device page.