End-of-study in accordance with the investigation protocol

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

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

• The review committee concerned (accredited MREC or CCMO),
• CCMO as competent authority for clinical investigations with medical devices at devices@ccmo.nl.

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

Other clinical investigations (MDR article 82) or studies with a positive decision prior to 26 May 2021

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