Below you will find the relevant legislation for clinical investigations with medical devices.
EU Medical Device Regulation (MDR)
Specific rules for the submission, assessment and conduct of clinical investigations with medical devices are laid down in the EU Medical Devices Regulation (EU no 2017/745, MDR). The legal framework for clinical investigation with medical devices are set out in chapter 6 of the MDR.
The MDR has three different frames for clinical investigations, which can be found in articles 62, 74 and 82. Each frame has different requirements and procedures.
Medical Research Involving Human Subjects Act (WMO)
The Dutch Medical Research Involving Human Subjects Act [Wet medisch-wetenschappelijk onderzoek met mensen, WMO] is relevant to aspects of clinical investigations that must be regulated at the national level. These include the way in which the assessment of clinical investigations is organised in the Netherlands and the procedures for clinical investigations with medical devices that fall under article 82 of the MDR.
Central Review of Medical Research Involving Human Subjects Decree (BCB)
The Dutch Central Review of Medical Research Involving Human Subjects Decree [Besluit centrale beoordeling medisch-wetenschappelijk onderzoek, BCB] determines for which types of research CCMO is the designated review committee. The BCB stipulates that CCMO is the designated review committee for research involving pregnant and/or breastfeeding women.
Medical Devices Act
The Dutch Medical Devices Act [Wet medische hulpmiddelen] contains organisational matters that are left to the national governments to regulate.