Labeling, Instructions for Use, and Manuals
Summary
Labeling, Instructions for Use (IFU), and manuals are critical user-facing documents that ensure safe and effective device operation. These documents must comply with specific regulatory requirements, include mandatory symbols and information, and be translated into local languages for each target market. They serve as the primary communication between you and your device users, providing essential safety information, operating instructions, and regulatory compliance details.
Why is Labeling, Instructions for Use, and Manuals important?
Medical device labeling and instructions exist to protect patient safety and ensure proper device utilization. Regulatory authorities require these documents because inadequate instructions are a leading cause of medical device incidents and user errors. Your IFU and labeling serve as the final safety barrier between your device and potential harm to patients or users.
These documents also fulfill your legal obligation to provide users with all necessary information for safe and effective device operation. Without proper labeling and instructions, your device cannot be legally marketed, and you may face significant liability if users are harmed due to inadequate information. The regulatory framework ensures that users receive consistent, comprehensive information regardless of the device manufacturer.
Regulatory Context
Under 21 CFR Part 820.120 (Device Labeling):
- Labeling must be legible and permanent
- Must include all information required by 21 CFR Part 801 (Labeling)
- Instructions for Use must be adequate for intended use
- Must comply with UDI requirements under 21 CFR Part 830
- Language requirements follow 21 CFR 801.15 (Medical device labeling written, audio, or visual information)
Special attention required for:
- Software devices requiring specific cybersecurity labeling (FDA Guidance on Cybersecurity)
- Prescription vs. over-the-counter labeling requirements (21 CFR 801.109)
- Combination products requiring coordinated labeling approaches
- 510(k) predicate device labeling consistency requirements
Under 21 CFR Part 820.120 (Device Labeling):
- Labeling must be legible and permanent
- Must include all information required by 21 CFR Part 801 (Labeling)
- Instructions for Use must be adequate for intended use
- Must comply with UDI requirements under 21 CFR Part 830
- Language requirements follow 21 CFR 801.15 (Medical device labeling written, audio, or visual information)
Special attention required for:
- Software devices requiring specific cybersecurity labeling (FDA Guidance on Cybersecurity)
- Prescription vs. over-the-counter labeling requirements (21 CFR 801.109)
- Combination products requiring coordinated labeling approaches
- 510(k) predicate device labeling consistency requirements
Under EU MDR 2017/745:
- Must comply with Annex I Chapter III (Information supplied by the manufacturer)
- Labeling requirements specified in Article 10 and GSPR 23
- Instructions for Use must follow GSPR 23.1 requirements
- Must include UDI as per Article 27 and Commission Implementing Regulation (EU) 2017/2226
- Language requirements per Article 10(11) - local language of intended market
Special attention required for:
- Electronic IFU provisions under GSPR 23.1(s) - specific conditions must be met
- Authorized representative information for non-EU manufacturers (Article 11)
- Implantable device specific labeling requirements (GSPR 23.2)
- Class III and implantable device patient cards (Article 18)
Guide
Understanding Document Types
Your labeling and instruction documentation consists of three primary components: the device label (physical or electronic labeling on the device), Instructions for Use (comprehensive user guidance), and supplementary manuals (user manuals, physician handbooks, marketing materials).
The device label contains essential identification and safety information that must be immediately visible to users. This includes your device name, manufacturer information, UDI, CE marking, software version, and critical warnings. The label serves as the first point of contact between users and your device’s regulatory status.
Instructions for Use (IFU) provide comprehensive guidance for safe and effective device operation. Your IFU must include intended purpose, indications for use, contraindications, warnings and precautions, user instructions, technical specifications, and contact information. The IFU can be provided electronically under specific conditions defined in GSPR 23.1.
Supplementary manuals include user manuals with detailed operational guidance, physician handbooks for healthcare provider-specific information, and marketing content that complies with regulatory advertising requirements. These documents support the primary IFU with additional context and detailed instructions.
Content Requirements
Your device identification section must include the device name exactly as registered, manufacturer name and address, UDI (both DI and PI components), software version for software devices, and date of manufacture or release. This information enables traceability and proper device identification throughout its lifecycle.
Safety information forms the core of your regulatory compliance. Include all contraindications based on your risk analysis, warnings and precautions derived from your risk controls, known side effects or adverse events, and emergency contact procedures. This information must be prominently displayed and easily understood by your intended users.
Operational guidance should provide step-by-step instructions for device setup and use, minimum system requirements for software devices, training requirements for users, troubleshooting guidance for common issues, and maintenance or care instructions. Your instructions must be sufficient for users to operate the device safely without additional training unless specifically required.
Symbol and Language Requirements
You must include mandatory symbols according to ISO 15223-1:2016 standards. Essential symbols include the medical device symbol, CE marking, manufacturer symbol, date of manufacture, UDI symbol, and caution/warning symbols. Each symbol must be accompanied by its meaning in your symbol explanation section.
Language requirements vary by market but generally require local language versions for user-facing documents. Your English master version serves as the source for translations, which must maintain regulatory accuracy while adapting to local linguistic requirements. Professional translation is recommended for regulatory documents to ensure compliance and clarity.
Electronic Instructions for Use
Electronic IFU (eIFU) can replace paper instructions under specific conditions defined in GSPR 23.1. You must ensure the target user group has access to electronic means, provide the website URL on the device label, ensure website availability throughout device lifetime, and provide paper copies upon request at no additional cost.
Your eIFU implementation requires a dedicated webpage with direct access to instructions, version control to ensure users access current information, accessibility compliance for users with disabilities, and backup systems to ensure continuous availability. The electronic format must not compromise user access to critical safety information.
Translation and Localization
Translation strategy should begin with a comprehensive English master document that serves as your source for all translations. Identify target markets and their language requirements early in your development process. Professional medical translation services ensure regulatory compliance and technical accuracy.
Quality control for translations includes back-translation verification, regulatory review by local experts, consistency checks across all translated materials, and regular updates when source documents change. Maintain version control across all language versions to ensure consistency and regulatory compliance.
Example
Scenario: You develop a smartphone application for diabetes management that analyzes blood glucose trends and provides lifestyle recommendations. Your device requires comprehensive labeling and instructions to ensure safe use by patients and healthcare providers.
Your device label includes the app name “GlucoTracker Pro,” your company information, CE marking, UDI identifier, current software version “2.1.3,” and release date. The label prominently displays the medical device symbol and includes a QR code linking to electronic instructions.
Your Instructions for Use begin with device identification and intended purpose: “GlucoTracker Pro is intended for use by adults with Type 1 or Type 2 diabetes to track blood glucose levels and receive lifestyle recommendations.” The IFU includes contraindications such as “Not intended for insulin dosing decisions” and warnings about “Consulting healthcare providers for significant glucose pattern changes.”
The operational section provides step-by-step setup instructions: “Download from official app store, create secure account with email verification, input baseline health information as guided by setup wizard, connect compatible glucose meter via Bluetooth, calibrate device according to meter manufacturer instructions.” Detailed screenshots accompany each step.
Safety information includes precautions: “This device does not replace regular medical care. Consult your healthcare provider before making significant treatment changes. In case of severe hypoglycemia or hyperglycemia, seek immediate medical attention.” Contact information for technical support and adverse event reporting is prominently displayed.
Your symbol explanation table defines each regulatory symbol used, including the medical device symbol (“Indicates this product is a medical device”), CE marking (“European conformity declaration”), and caution symbol (“Indicates important safety information requiring user attention”).