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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