Notifications of clinical investigations with medical devices to CCMO as of 1 October
Starting 1 October 2020, CCMO will be the competent authority for clinical investigations with medical devices. This means that from then on, CCMO will take over the tasks of the Health and Youth Care Inspectorate (IGJ) for processing the notification of these investigations.
As of 1 October 2020, manufacturers should notify CCMO of clinical investigations involving a medical device. This notification only involves a change of email address; all remaining notification procedures will stay the same. Clinical investigations of which the IGJ has already been notified before 1 October should report serious adverse events (SAEs) and (premature) end of investigation to CCMO starting 1 October. For more information, please consult our website.
The transfer of these tasks from IGJ to CCMO takes place in anticipation of the EU Medical Device Regulation (MDR) 2017/745, which will take effect from 26 May 2021. The task-shift has been laid down in the Medical Devices Decree and the Active Implants Decree.
As of 1 October, notifications and questions on clinical investigations with medical devices may be sent to email@example.com.