IMDRF document

Personalized Medical Devices - Regulatory Pathways

IMDRF Technical document · IMDRF/PMD WG/N58 FINAL:2023 (Edition 2) · posted Sep 14, 2023

Key facts

Title Personalized Medical Devices - Regulatory Pathways
Document reference IMDRF/PMD WG/N58 FINAL:2023 (Edition 2)
Issued by IMDRF
Document category Technical document
Posted Sep 14, 2023
IMDRF page imdrf.org
Document file imdrf.org

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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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