Lorenzo Tempesti -

The MDCG has recently issued a new guideline to outline the clinical investigation reporting procedure.

According to the guideline the reportable events are:

  1. any serious adverse event having a causal relationship (even if reasonably possible) with the investigational device, the comparator, or the investigation procedure
  2. any device deficiency that might have led to a serious adverse event
  3. any new findings in relation to any event referred to in points a) and b)

The guideline also states the timelines for the sponsor to notify the event to the Competent Authority:

  • Immediately, but not later than 2 calendar days for all reportable events which indicate an imminent risk of death, serious injury, or serious illness
  • Immediately, but not later than 5 calendar days for any other reportable events

Moreover, starting from 26 May 2021 until EUDAMED will be implemented a new Summary Reporting Form (available on MDCG Docs room) shall be use to transmit the reporting to the relevant Competent Authorities.

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