IMDRF · International guidance
IMDRF/RPS WG/N13:2024 (Ed 4)
IVD Medical Device Regulatory Submission Table of Contents
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/RPS WG/N13:2024 (Ed 4)
- Published (source metadata)
- June 25, 2024
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About this guidance
IVD Medical Device Regulatory Submission Table of Contents
Standardized table of contents for IVD medical device regulatory submissions. Edition 4 with updated structure for global harmonization.