Notifications of studies with a positive decision prior to May 26, 2021

Studies requiring notification

• Notifiable studies with a medical device
  • The notification requirement applies both to medical devices without a CE mark and to medical devices with a CE mark used outside their intended use (new indication). This intended use is defined in the relevant conformity assessment procedure of the medical device concerned.
• Non-notifiable studies with medical devices
  • When the study involves the use of CE-marked medical devices and the intended use of the medical device is the same as that intended by the relevant conformity assessment procedure, the study does not require notification.
  • Clinical investigations approved under the MDR do not require notification to CCMO.

Reported research

Regarding studies with medical devices that has already been reported to the IGJ, SAEs and (premature) end-of-study must also be reported to CCMO.

Notification procedure

The following notifications may be sent to devices@ccmo.nl. Other matters (e.g. amendments) do not have to be reported.

• Notification of study
  Notification of a study with a medical device must take place by means of the declaration as referred to in Annex VIII of the Medical Devices Directive (MDD), Council Directive 93/42/EEC. This declaration requires the attachment of various documents. An overview (in Dutch) of the documents to be submitted with the declaration can be found at Documents notification clinical investigation with a medical device.

• Notification of serious adverse events (SAEs)
  Serious adverse events (SAEs) occurring during clinical trials with medical devices must also be registered and reported to CCMO. For investigations subject to the Dutch Medical Research Involving Human Subjects Act [Wet medisch-wetenschappelijk onderzoek met mensen, WMO], this happens automatically with submission through ToetsingOnline.
  SAEs in investigations not subject to the Dutch WMO (nWMO) should be reported both to CCMO and to MREC. More information on this subject can be found on Safety report.
• Reporting (premature) termination of the trial
  The manufacturer is required to report the end of a clinical investigation with a medical device to the MREC concerned and to CCMO. The periods of time stipulated in the MDR will be adhered to.
  • If the study is ended prematurely on the grounds of safety reasons, the manufacturer should report this immediately to CCMO. The same method of reporting can be used for this notification as for reporting to the MREC.
  • Other notifications regarding the end-of-study in the Netherlands should be carried out within 15 days. If the study is terminated earlier than anticipated in the protocol, the motivation for the early termination should be included in the report.