IMDRF · International guidance
IMDRF/GRRP WG/N47:2024 (Ed 2)
Essential Principles of Safety and Performance
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/GRRP WG/N47:2024 (Ed 2)
- Published (source metadata)
- April 26, 2024
Readable full text
Open a language version
Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
About this guidance
Essential Principles of Safety and Performance
Essential principles of safety and performance for medical devices and IVD medical devices. Edition 2 foundation document for global regulatory alignment.