Notification from 1 October 2020
Starting 1 October 2020, CCMO will be the competent authority for clinical investigations involving medical devices. This means that from then on, CCMO will take over the tasks of the Healthcare and Youth Inspectorate (IGJ) for processing notifications for clinical investigations involving medical devices.
As of 1 October 2020, manufacturers should clinical research with medical devices to CCMO. This applies to both medical devices without CE marking and medical devices with CE marking used outside their intended purpose as defined by the relevant conformity assessment procedure (new indication). If the clinical investigation involves the use of CE-marked medical devices used within their intended purpose as defined by the relevant conformity assessment procedure, the clinical investigation does not have to be reported.
Clinical investigations of which IGJ has already been notified should report serious adverse events (SAEs) and (premature) end of investigation to CCMO starting 1 October 2020.
The procedures will stay the same. The following notifications may be sent to firstname.lastname@example.org. Other matters do not have to be reported.
- Notification of clinical investigation
- Reporting serious adverse events
- Report suspension and (premature) end of study