CASafetyReporting object
Sponsor
Other
Sponsor or other organization designated by sponsor
Competent Authority
CA(s) of EU&EFTA Member States concerned
Relevant EC(s)
SAE (Serious Adverse Event)
SADE (Serious Adverse Device Effect)
Device deficiency, potentially leading to SAE
Within a max of 2 d upon first knowledge for events being fatal, life-threatening, or deteriorating health
As soon as possible, within a max of 7d upon first knowledge (for other AEs or AEs related to MD deficiencies, potentially leading to a SAE)
European standard SAE reporting form MEDDEV 2.7/3 to be used
Trials not submitted through RNEC (before January 2016): On-line: Format ICH E2B/EudraVigilance CIOMS Form to email: farmacovigilancia.ec@infarmed.pt Trials submitted through RNEC (after January 2016): DSURs submitted through RNEC
Yes
National CA
Relevant EC(s)
The reporting timelines are according to Art 22 Law 21/2014 (pt), Annex XVI (23) DL 145/2009 (pt) and in line with the EC’s guidance document MEDDEV 2.7/3 on SAE reporting in clinical investigations under directives 90/385/EEC and 93/42/EC)
Art 22 (10) Law 21/2014 (pt) (Annual Safety Report)
An Annual Safety report is mandatory for clinical investigations of MD requiring authorisation by CA.
Given reporting timelines apply to all clinical investigations of MD.
Sponsor
Immediately (not later than 24h)
Followed by detailed written report within 5d