CASafetyReporting object

Sponsor

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

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

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)

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 med-udstyr@dkma.dk

Email

Yes

National CA

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.

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