29 January 2024
Draft
IMDRF/SaMD WG/N81 DRAFT: 2024
Medical Device Software:
Considerations for Device and
Risk Characterization
AUTHORING GROUP
IMDRF Software as a Medical Devic
AM\1291770EN.docx PE757.081v01-00
EN United in diversity EN
European Parliament
2019-2024
Committee on Industry, Research and Energy
2023/0131(COD)
30.11.2023
AMENDMENTS
350 - 535
Draft opi