SAE (Serious Adverse Event)
SADE (Serious Adverse Device Effect)
Any events with the potential to influence safety of a subject
Within a max of 7d from the day when the event occurred
"Form for medical incident notification"/ "Formularz zgłoszenia incydentu medycznego" (in en/pl).
Form available on the URPL website.
Art 51 Medical Device Act 2010 (en) / Dz.U. 2010 nr 107 poz. 679 (pl)
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).