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Glossary Term
Device Labeling
Definition
Device Labeling encompasses all labels, instructions for use (IFU), and other information provided with a medical device to inform users about its intended purpose, proper usage, safety precautions, and regulatory compliance. It is a critical component of medical device packaging and is governed by stringent regulatory requirements such as FDA 21 CFR Part 801 and EU MDR.
Relevance to the MedTech Industry
Device labeling ensures that healthcare providers, patients, and other stakeholders have accurate and accessible information to safely and effectively use the device. It also demonstrates compliance with regulatory standards and serves as a key communication tool between the manufacturer and the end-user.
Additional Information & Related Terms
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