Netherlands: Notifications of clinical investigations with medical devices to CCMO as of the 1st of October
From the 1st of October 2020, manufacturers of medical devices must register clinical investigations with the Dutch Central Committee on Research Involving Human Subjects (CCMO). The Committee will take over the tasks of the Healthcare and Youth Inspectorate (IGJ) for processing notifications for clinical trials with medical devices.
What must be reported or notified?
- Notification of medical devices investigations if they involve obtaining CE marking or extending CE marking indications
- Reporting serious adverse events (SAEs)
- Report suspension and premature end of the study
How to do it?
Manufacturers are obliged to send notifications and reports to devices@ccmo.nl and review committee.
An online tool called Committee finder offers a solution to easily find the competent authority for the registration of clinical investigations.
For more details visit the CCMO website.
Do you know how to report or notify the Committee?
Contact Meditrial to learn everything you need to know on how to prepare necessary documentation and use the Committee finder tool! With us, you will be the first to comply.
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Table of Contents
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on [...]
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
