Reporting of SAEs

The regulation clarifies which serious adverse events (SAEs) the sponsor must report to the Danish Medicines Agency.

The Danish Medicines Agency is notified of serious adverse events related, or possibly related, to devices or the investigation procedure by way of the European Commission’s Excel template in the guidance document MDCG 2020-10/2 ”Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745”.

The Excel overview containing the serious adverse events subject to reporting is submitted to the Danish Medicines Agency and must clearly specify “SAE” and the CIV-ID in the subject field and the Danish Medicines Agency’s case number. The regularly submitted reports are only to be sent to the Danish Medicines Agency and not the Medical Research Ethics Committees.