Suspension
The sponsor is responsible for the timely reporting of the suspension of the IVD performance study via a Status Progress in the Research Portal. The sponsor should always cite the reason for the suspension.
In the event of a suspension for safety reasons, the sponsor must notify within 24 hours all EU Member States in which the performance study is carried out.
In the event of a suspension for reasons other than safety, the sponsor must report this within 15 calendar days.
IVD performance studies with a suspension for safety reasons may only be restarted upon approval by the review committee. The restart permission is requested by submitting an amendment in the Research Portal. The restart of the performance must be reported in the Research Portal with a Status Progress.
Sample form
A sample form is available, showcasing the questions to be answered.
Attention: This form is only a sample template of the questionnaire that must be completed online. It cannot be completed or submitted in this format.