All terms

Labeling

All written, printed, or graphic matter on or accompanying a device.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

Per FD&C Act, labeling includes any written, printed, or graphic matter accompanying a medical device, encompassing the IFU, package labels, and patient information leaflets.

What this means in practice

Labeling errors are a leading cause of recalls and Form 483 citations. EU MDR adds harmonized symbols and electronic IFU rules.

Cross-references

Uses

Concepts or artefacts this term builds on.

ISO 15223-1 Symbols

Contains

Sub-elements or required artefacts of this term.

Electronic Instructions for Use(eIFU)

Mentioned in recent activity

1 entry

Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

Class II· 2026-03-04

Primary references

3 sources

Link health: 2 verified 1 needs review· last checked 2026-05-09

FDA·1IMDRF·1RAPS·1

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