IMDRF · International guidance
IMDRF/AET WG/N85:2024
Common Data Set for Adverse Event Data Exchange Between Regulators
International Medical Device Regulators ForumIMDRFTechnical guidance
International guidance
This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.
Source identity
- Issuing body
- IMDRF
- Reference
- IMDRF/AET WG/N85:2024
- Published (source metadata)
- October 10, 2024
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About this guidance
Common Data Set for Adverse Event Data Exchange Between Regulators
Common data set specification for adverse event data exchange between IMDRF regulatory authorities. Enables standardized vigilance information sharing.