CASafetyReporting object

Responsible for AE reporting to CA


Sponsor must declare reportable events to

National CA
CA(s) of EU&EFTA Member States concerned

Reportable AEs

SAE (Serious Adverse Event)
SAE (Serious Adverse Event) - Near Incidents

SAE /SADE must be reported

Immediately, not later than 2d (SAE indicating an imminent risk of death, serious injury, or serious illness)
Immediately, not later than 7d upon first knowledge (any other SAE)

Standard Reporting Form

The forms are available in section Medicines & medical devices / Medical devices / Clinical investigations / Application:
(1) Notification of serious adverse events and near-incidents with medical devices during a clinical investigation
(2) EU Commission's SAE Reporting form (Excel)

Notification format:
Per Email to

Reporting format - Options


Provision of Annual safety report mandatory


Annual safety report shall be provided by sponsor to

National CA

Guidance on AE reporting procedure

The conditions for AE reporting stipulated by the DHMA correspond to the guidance provided in the EU Commission guidelines on reporting of adverse events ”Guidelines on medical devices. Clinical investigations: Serious adverse event reporting” MEDDEV 2.7/3.

Additional Information

All other adverse events (not categorised as „serious“) must be declared in the final report.