ECSafetyReporting object
Reportable AEs
AE (Adverse Event)
SAE (Serious Adverse Event) arising from the testing of the MD
Investigator shall report SAE to
Sponsor
Reporting timeline
Immediately
Responsible for AE reporting to relevant EC(s)
Sponsor
SAE/SADE must be reported
Immediately
Sponsor is obliged to notify all investigators of SAE/ SADE occurrence
Yes
Provision of Annual safety report mandatory
Yes
Applicable national legal framework/ Reference
Section 19 of Act No 268/2014 on Medical Devices
Section 2 of Decree No 62/2015
Additional Information
Annual safety report: shall be provided no later than by 31 January of the following year