ECSafetyReporting object

Adverse Events (AE) - Definitions (pursuant to national law)

SAE: Any untoward occurrence that may led to death or led to serious deterioration in the health of the subjects, according to Art 3, DL 145/2009 (pt).

Reportable AEs

SAE (Serious Adverse Event)
Device deficiency, potentially leading to SAE

Investigator shall report SAE to

Sponsor

Reporting timeline

Immediately (not later than 24h)
Followed by detailed written report within 5d

Responsible for AE reporting to relevant EC(s)

Sponsor

SAE/SADE must be reported

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)

National Standard Reporting form available

European standard SAE reporting form MEDDEV 2.7/3 to be used

Standard Reporting Form

The standard SAE reporting form: Appendix of MEDDEV 2.7/3.

Reporting format - Options

Online portal
On-line through RNEC

Provision of Annual safety report mandatory

Yes

National legal framework in place

Yes

Applicable national legal framework/ Reference

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)

Additional Information

An Annual Safety is mandatory for clinical investigations of MD requiring authorisation by CA and Ethical approval and shall be submitted to the competent EC and the national CA.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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