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Early termination

Has your IVD performance study ended earlier than foreseen in the protocol? If so, you are required to report this to the review committee (accredited MREC or CCMO).

Has your study been assessed by CCMO as review committee? If so, you are required to use the form Notification of end-of-study.

Download the Notification end-of-study form

Has your study been assessed by an accredited MREC? If so, please request information from the MREC concerned on its reporting policy.

IVD performance studies (IVDR article 58/70(2)) or post-market performance follow-up studies (PMPF, IVDR article 70.1)

In the event of an early termination for safety reasons, the sponsor must notify within 24 hours:

  • all EU Member States in which the 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 an early termination of studies in the Netherlands for reasons other than safety, the sponsor must notify within 15 calendar days:

  • the review committee (accredited MREC or CCMO),
  • CCMO as competent authority for performance studies with IVDs at devices@ccmo.nl.

Studies with a positive decision prior to 26 May 2022 (WMO article 10, section 5b)

The sponsor is required to report the early termination to the review committee concerned (accredited MREC or CCMO) within 15 calendar days.