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
Rates 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 ...
Read moreResearch from CTIS included in OMON
From May 2026, studies from the CTIS public portal are included in the Overview of Medical Research in the Netherlands (OMON). ...
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Template IRP (in Dutch: IVO) presented to Minister Hermans
Today, Wednesday, May 27, 2026, Minister Sophie Hermans of Health, Welfare and Sport received the first official copy of the ...
Read moreIRP (in Dutch: IVO) in use from 1 June 2026
The Information Sheet for Research Participants (IRP, in Dutch: Informatiebrief voor Onderzoeksdeelnemers, IVO) can be used from ...
Read moreLaunch new information sheet IRP postponed
Unfortunately, CCMO has had to postpone the launch of the Information Sheet for Research Participants (IRP, in Dutch ...
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