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Early termination

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

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 early termination for safety reasons, the sponsor must notify within 24 hours:

  • all EU Member States in which the clinical investigation is carried out,
  • the review committee concerned (accredited MREC or CCMO),
  • CCMO as competent authority for clinical investigations with medical devices at devices@ccmo.nl.

In the event of an early termination of clinical investigations 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 clinical investigations with medical devices at devices@ccmo.nl.

Other clinical investigations (MDR article 82) or studies with a positive decision prior to 26 May 2021 (WMO article 10, subsection 5b)

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