Current affairs
EU In Vitro Diagnostics Regulation
On May 26, 2022, the EU In Vitro Diagnostics Regulation (IVDR) has come into effect with specific rules for the submission, review and conduct of performance studies using in vitro diagnostics.
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EU Clinical Trial Regulation (CTR)
On January 31, 2022, the EU Clinical Trial Regulation (CTR) 536/2014 has come into effect with new rules for research with medicinal products in the European Union. From January 31, 2023, all initial applications of research with medicinal products will be submitted via CTIS.
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EU Medical Device Regulation (MDR)
On May 26, 2021, the EU Medical Device Regulation 2017/745 (MDR) has come into effect with specific rules for the submission, review and conduct of clinical investigations with medical devices.
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News
OMON and Research Portal temporarily unavailable
Update 21 October 2026, 18:45: Both the Research Portal and the onderzoekmetmensen.nl website are now available again. Serious ...
Read moreUpdate to Research Protocol
Today, 28 September 2026, new versions of the model research protocol have been published. Both the template for WMO research ...
Read moreNew version of IVO now available
A new version of the template for the information sheet for research participants (IRP, in Dutch: IVO) is now available. This ...
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Sipko Mülder new general secretary/director CCMO
Sipko Mülder took office as general secretary/director of the CCMO on July 1. He succeeds Stan van Belkum, who led the national ...
Read moreRates 2027: assessment of research under CTR, MDR and IVDR
The Ministry of Health, Welfare and Sport has set the rates for 2027 for medical ethical review in the Netherlands of research ...
Read moreWebpages safety reporting in CTR studies adjusted
In order to make the information about safety reporting in CTR studies more accessible, the webpages concerning this subject have ...
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