End-of-study in accordance with the investigation protocol
Has your clinical investigation ended as defined in the investigation protocol? If so, please report the end date of the investigation in 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 end-of-study as defined in the investigation protocol, the sponsor must report this in the Research Portal within 15 calendar days.
This deadline applies both to the end date of the research in the Netherlands and to the end date of the investigation in all EU Member States as well as worldwide.
Other clinical investigations (MDR article 82) or studies with a positive decision prior to 26 May 2021
The sponsor must report the end date in the Research Portal within 56 calendar days (8 weeks).
This deadline applies both to the end date of the investigation in the Netherlands and to the end date of the investigation in all EU Member States as well as worldwide.