Labeling is all written, printed, or graphic information appearing on the medical device, its packaging, or accompanying the device, including instructions for use and safety information.
Complete Guide to Labeling
Labeling encompasses all written, printed, or graphic matter affixed to or accompanying a medical device, including packaging labels, instructions for use (IFU), and promotional materials. Proper labeling is a fundamental regulatory requirement for medical devices globally.
Regulatory frameworks:
- USA (21 CFR 801) - FDA labeling requirements for medical devices
- EU MDR Annex I - General safety and performance requirements including labeling
- ISO 15223-1 - Symbols for use in medical device labels
- ISO 20417 - Information to be supplied by the manufacturer
Essential labeling elements:
- Device name and model/catalog number
- Manufacturer name and address
- Authorized representative (for EU)
- Unique Device Identifier (UDI) when required
- Intended use and indications
- Warnings, precautions, and contraindications
- Sterilization information (if applicable)
- Manufacturing date and expiration/use-by date
- Batch/lot number
- Storage and handling conditions
- Instructions for use (IFU)
Instructions for Use (IFU):
The IFU is a critical component of device labeling that must include:
- Detailed operating instructions
- Assembly and installation guidance
- Safety warnings and precautions
- Maintenance and cleaning procedures
- Troubleshooting information
- Performance specifications
- Adverse event reporting information
Symbols and pictograms:
ISO 15223-1 standardizes symbols used on medical device labels, such as:
- Manufacturer symbol
- Date of manufacture
- Use-by date
- Sterilization indicators
- Temperature limits
- Do not re-use symbol
- Prescription only indicator
Multi-language requirements:
- EU: Labeling must be in the official language(s) of the member state where the device is marketed
- Canada: English and French required
- Brazil: Portuguese mandatory
- China: Chinese required for domestic market
- Many countries require both native language and English
UDI requirements:
The Unique Device Identifier system requires carriers (barcodes) on device labels:
- USA: FDA UDI rule (2013)
- EU: UDI required under EU MDR
- Format: GS1, HIBCC, or ICCBBA standards
Digital labeling trends:
Electronic IFU (eIFU) is becoming accepted in many jurisdictions to reduce paper waste and provide up-to-date information, though physical labeling remains mandatory for critical warnings.
Related Terms
More Documentation
View allA public document summarizing the 510(k) substantial equivalence determination submitted to the FDA.
A formal written statement by the manufacturer that a medical device meets all applicable EU MDR requirements and is ready for CE marking.
A compilation of records describing the design history of a finished medical device, required by FDA 21 CFR Part 820.
Instructions for Use - comprehensive documentation provided by the manufacturer that gives users the information necessary for safe and effective use of a medical device.
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