IMDRF · International guidance
IMDRF/PMD WG/N58:2023 (Ed 2)
Personalized Medical Devices - Regulatory Pathways
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/PMD WG/N58:2023 (Ed 2)
- Published (source metadata)
- September 14, 2023
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About this guidance
Personalized Medical Devices - Regulatory Pathways
Regulatory pathways for personalized medical devices including patient-matched and custom-made devices. Edition 2 with updated guidance.