Timelines other medical scientific research (WMO)

For ‘general’ medical research, that is, not a research with a medicinal product, a so-called ‘reasonable timeline’ of 8 weeks applies, on the grounds of the General Administrative Law Act (Awb, in Dutch). This means that the MREC or CCMO has a maximum of 8 weeks to reach a decision, unless the MREC or CCMO has given notice of requiring more time, though this must be made known within that timeline. If this is the case the MREC or CCMO must state the extension timeline during which a decision can be expected. The MREC or CCMO usually applies a very reasonable and short (as possible) extension to the initial timeline. The extension can have a maximum duration of 8 weeks.

For clinical investigations with medical devices (MDR) and performance studies using in vitro diagnostics (IVDR), specific review timelines are set in MDR and IVDR. 

Clock stop

The MREC or CCMO can stop a timeline for a set period (clock stop) if they have questions/suggestions regarding a submission. If this is the case, they will let the submitting party know by way of written letter. The timeline starts again at the moment the MREC or the CCMO has received the reaction by the submitting party. Once again, they will let the submitting party know of this in the form of a written letter. They will also give the timeline during which the decision will be made. The MREC sends its decision within 7 working days to the submitting party.

Failure of the MREC or the CCMO to reach a decision concerning a request for review within the set timelines can result in the Penalty and Appeal Act (Wet dwangsom en beroep bij niet tijdig beslissen, in Dutch).