Incident Reporting
Links to the notification form published on the European Commission’s website are included and can be completed and sent by e-mail to psvigilancia@aemps.es
- Serious Incident Report Form (https://ec.europa.eu/docsroom/documents/41681)
- Help text for the completion of the Serious Incident Report Form (https://ec.europa.eu/docsroom/documents/37350)
- IMDRF codes
Common IMDRF Terminology and Adverse Event Codes for Serious Incident Reporting (https://www.imdrf.org/working-groups/adverse-event-terminology)
The International Medical Devices Regulators Forum (IMDRF) consists of medical device regulators from different territories working together to accelerate international harmonization and regulatory convergence in the field of medical devices.
The common terminology and codes for adverse events developed within the IMDRF provide a useful tool for serious incident reporting of medical devices and in vitro diagnostic medical devices that will facilitate data analysis and signal detection. This terminology is composed of four types of codes/terms: product failure, health effects, investigation of the cause, and parts or components of the product.
- IMDRF Document on Terminology for Categorization of Adverse Events (https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-200318-ae-terminologies-n43.pdf)
Safety Corrective Action Reporting
Links to the reporting form published on the European Commission website that can be completed and submitted by e-mail to psvigilancia@aemps.es
- Safety Corrective Action Notification Form (https://ec.europa.eu/docsroom/documents/32305/attachments/4/translations)