CASafetyReporting object
Sponsor must declare reportable events to
National CA
Relevant EC(s)
Reportable AEs
SAE (Serious Adverse Event)
SADE (Serious Adverse Device Effect)
Any events with the potential to influence safety of a subject
SAE /SADE must be reported
Within a max of 7d from the day when the event occurred
National standard reporting form available
Yes
Standard Reporting Form
"Form for medical incident notification"/ "Formularz zgłoszenia incydentu medycznego" (in en/pl).
Form available on the URPL website.
Provision of Annual safety report mandatory
Yes
Annual safety report shall be provided by sponsor to
National CA
Applicable national legal framework/ Reference
Art 51 Medical Device Act 2010 (en) / Dz.U. 2010 nr 107 poz. 679 (pl)
Additional Information
An annual safety report shall be submitted to the CA clinical investigations on MD (interventional and observational) and registries (MD CE-marked used within label are exempted from this obligation).
