Clinical research involving the use of medical devices
A manufacturer is required to perform a clinical evaluation before being allowed to put a medical device on the market. A clinical investigation may form part of the clinical evaluation.
Legal requirements apply to the performance of a clinical investigation with a medical device that may not yet be marketed commercially for a specific purpose. The Inspectorate maintains supervision over compliance with this legislation.
The page explains how the Health and Youth Care Inspectorate (IGJ) performs the supervision over clinical investigations involving the use of medical devices.
Notification of clinical investigation with medical devices goes through to the CCMO
Starting October 1, 2020, CCMO will be the (only) competent authority for clinical investigations with medical devices. This means that from then on, CCMO will take over the Health Care and Youth Inspectorate (IGJ) tasks for processing the notification of these investigations.
As of October 1, 2020, manufacturers should notify CCMO of clinical investigations involving a medical device. This notification only consists of a change of email address ; all remaining notification procedures will stay the same. Clinical investigations of which the IGJ has already been notified should report serious adverse events (SAEs), suspension and (premature) end of investigation to CCMO. For more information, please consult the website.
The transfer of these tasks from IGJ to CCMO occurs in anticipation of the Medical Device Regulation (MDR), also known as Regulation (EU) 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.
Notifications and questions on clinical investigations research with medical devices may be sent to email@example.com as of October 1, 2020.