IMDRF · International guidance
IMDRF/GRRP WG/N52:2024 (Ed 2)
Principles of Labelling for Medical Devices and IVD Medical Devices
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/N52:2024 (Ed 2)
- Published (source metadata)
- April 26, 2024
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About this guidance
Principles of Labelling for Medical Devices and IVD Medical Devices
Harmonized principles for medical device labeling including label content, IFU, and e-labeling. Edition 2 with updated requirements.