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
Committee 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 moreLabelling information improved
The content regarding the labelling of investigational medicinal products on the CCMO website has been updated.
Read moreCCMO.nl email alerts discontinued
Currently, users of the CCMO website can still use email alerts. Those who have enabled this feature receive an email as soon as ...
Read moreCCMO participates in pilot coordinated assessment
CCMO is participating in the EU pilot for coordinated assessment. Until EUDAMED becomes available medical devices under the MDR ...
Read moreRevised version of PIF template published
Today a revised version of the PIF template, the template subject information sheet (SIS), was published. This document is only ...
Read moreSponsors can sign up to participate in the COMBINE pilot
CCMO is looking for sponsors to participate in the pilot all-in-one procedure of the European COMBINE program. This program aims ...
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