Relevant legislation

IVDR

Specific rules for the submission, assessment and conduct of IVD performance studies  are laid down in the EU In Vitro Diagnostics Regulation (EU no 2017/746, IVDR). The legal framework for IVD performance studies is set out in chapter 6 of the IVDR.

The IVDR has different frames for performance studies which can be found in articles 57, 58 and 70. 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 performance studies that must be regulated at the national level. These include the way in which the assessment of performance studies is organised in the Netherlands.

The WMO also stipulates that CCMO is the designated review committee for non-therapeutic interventional research involving minors and/or incapacitated adult subjects.

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 the IVDR left to national governments to regulate.