Temporary halt
The sponsor is responsible for the timely reporting of the temporary halt of the investigation. The sponsor should always cite the reason for the temporary halt in the notification.
Clinical investigations for conformity purposes (MDR article 62/74.2) or post-market clinical follow-up investigations (MDR article 74.1)
In the event of a temporary halt for safety reasons, the sponsor must notify within 24 hours:
- all EU Member States in which the clinical investigation is carried out,
- the review committee concerned (accredited MREC or CCMO),
- CCMO as competent authority for clinical investigations with medical devices at devices@ccmo.nl.
In the event of a temporary halt of clinical investigations in the Netherlands for reasons other than safety, the sponsor must notify the following authorities within 15 calendar days:
- the review committee (accredited MREC or CCMO),
- CCMO as competent authority for clinical investigations with medical devices at devices@ccmo.nl.
Clinical investigations with a temporary halt for safety reasons may only be restarted upon approval by the review committee. The sponsor must report the restart of the clinical investigation to CCMO at devices@ccmo.nl.
Other clinical investigations (MDR article 82) or studies with a positive decision prior to 26 May 2021 (WMO article 10, subsections 4 and 5a)
The sponsor is required to report the temporary halt immediately (within 24 hours) to the review committee concerned (accredited METC or CCMO). Clinical investigations with a temporary halt for safety reasons may only be restarted upon approval by the review committee.