Temporary halt
The sponsor is responsible for the timely reporting of the temporary halt of the IVD performance study. The sponsor should always cite the reason for the temporary halt in the notification.
IVD performance studies (IVDR article 58/70(2)) or post-market performance follow-up study (PMPF, IVDR article 70(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 performance study is carried out,
- the review committee concerned (accredited MREC or CCMO),
- CCMO as competent authority for performance studies with IVDs at devices@ccmo.nl.
In the event of a temporary halt of IVD performance studies 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 performance studies with IVDs at devices@ccmo.nl.
IVD performance studies 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 performance study to CCMO at devices@ccmo.nl.
Studies with a positive decision prior to 26 May 2022 (WMO article 10, sections 4 and 5a)
The sponsor is required to report the temporary halt immediately (within 24 hours) to the review committee concerned (accredited MREC or CCMO). IVD performance studies with a temporary halt for safety reasons may only be restarted upon approval by the review committee.