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End-of-study in accordance with the study protocol

Has your IVD performance study ended as defined in the study protocol? If so, please report the end date of the study 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 58/74(2)) or post-market performance follow-up studies (PMPF, IVDR article 70(1))

In the event of an end-of-study as defined in the study protocol, the sponsor must notify within 15 calendar days:

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

This deadline applies both to the end date of the study in the Netherlands and to the end date of the study in all EU Member States as well as worldwide.

Studies with a positive decision prior to 26 May 2022

The sponsor must report the end date to the review committee concerned (accredited MREC or CCMO) within 56 calendar days (8 weeks). This deadline applies both to the end date of the study in the Netherlands and to the end date of the study in all EU Member States as well as worldwide.