CASafetyReporting object

Responsible for AE reporting to CA

Sponsor
Manufacturer acting as sponsor

Sponsor must declare reportable events to

Competent Authority
CA(s) of EU&EFTA Member States concerned
All participating sites

Reportable AEs

SAE (Serious Adverse Event)

SAE /SADE must be reported

Immediately (without delay)

National standard reporting form available

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

Standard Reporting Form

Reporting procedure and format: According to the European SAE reporting guidelines MEDDEV 2.7/3 (2010) including MEDDEV 2.7/3 Reporting form.

Guidance on AE reporting procedure

Related information is available on IGZ website in section: Home>English>Medical devices>Clinical research involving the use of medical devices or on CCMO website in section: Home>Investigators>Types of research>Research with a medical device

Additional Information

MDs with CE-mark, used within label: SAEs occurrring in a clinical investigation with CE mark must be reported by the manufacturer to the Health Care Inspectorate conform the Europena Guidelines on a MD vigilance system MEDDEV 2.12.1.
Reporting timelines: within 2 working days, and no longer that 4 calendar days about SAEs which have happened during the clinical trial in the participating centers (both in the Netherlands and other member states)

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