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.
Read more
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.
Read more
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.
Read more
News
Webpages 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). ...
Read more
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 ...
Read moreCommittee Finder and other tools no longer available
As of October 1, 2025, the committee finder, the clinical trial decision tool, and the clinical research e-learning tool will no ...
Read more