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


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


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).