CASafetyReporting object

Responsible for AE reporting to CA

Sponsor

Sponsor must declare reportable events to

National CA
CA(s) of EU&EFTA Member States concerned

Reportable AEs

SAE (Serious Adverse Event)

SAE /SADE must be reported

According to timelines specified in MEDDEV 2.7/3 December 2010

National standard reporting form available

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

Standard Reporting Form

Pre-market MD: Reporting of SAE/Incidents should be done according to the templates provided in Appendix (reporting form) of Meddev 2.7/3.

Provision of Annual safety report mandatory

No

Annual safety report shall be provided by sponsor to

Not required, but the CA could require it in case of device without CE mark or used off-label.Not

Guidance on AE reporting procedure available

Yes

Guidance on AE reporting procedure

Post market MDs (CE-marked use within label): Guidelines MEDDEV 2.12-2, rev.2 Jan 12. Reporting via the Medical Device Vigilance System
Pre market MDs: MEDDEV 2.7/3 December 2010 (serious adverse reporting)

National legal framework in place

Yes

Applicable national legal framework/ Reference

The international standard ISO14155:2011 (Clinical investigation of medical devices for human subjects – Good Clinical Practice) applies to all clinical investigations of MD.

Additional Information

Combination studies (MD+MP): Reporting obligations follow the requirements for IMP studies.

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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