Premature termination
Has your clinical investigation ended earlier than foreseen in the protocol? If so, you are required to report this through the Research Portal.
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 an early termination for safety reasons, the sponsor must notify within 24 hours all EU Member States in which the clinical investigation is carried out.
In the event of an early termination of clinical investigations in the Netherlands for reasons other than safety, the sponsor must report this through the Research Portal within 15 calendar days. The submission through the Research Portal suffices for both the review committee and the competent authority medical devices.
Other clinical investigations (MDR article 82) or studies with a positive decision prior to 26 May 2021 (WMO article 10, subsection 5b)
The sponsor is required to report the early termination within 15 calendar days through the Research Portal.