IMDRF document

Common Data Set for Adverse Event Data Exchange Between IMDRF Regulators

IMDRF Technical document · IMDRF/AET WG/N85 FINAL: 2024 · posted Oct 10, 2024

Key facts

Title Common Data Set for Adverse Event Data Exchange Between IMDRF Regulators
Document reference IMDRF/AET WG/N85 FINAL: 2024
Issued by IMDRF
Document category Technical document
Posted Oct 10, 2024
IMDRF page imdrf.org
Document file imdrf.org

At a glance

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About IMDRF and GHTF documents

IMDRF is a forum of medical device regulators that writes harmonised guidance, such as the MDSAP audit documents and the UDI, SaMD and adverse-event terminology documents. It also hosts the archived documents of its predecessor, the Global Harmonization Task Force (GHTF).

Source: International Medical Device Regulators Forum (IMDRF), including the archived documents of the Global Harmonization Task Force (GHTF) · Source date:

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