R-TF-012-037 Labeling and IFU Requirements
This document specifies the labeling and Instructions for Use (IFU) requirements for Legit.Health Plus. These requirements are derived from the risk management process documented in R-TF-013-002 Risk Management Record and ensure that adequate information is provided to users to mitigate identified risks through proper labeling and documentation.
The labeling requirements are developed in accordance with:
- MDR 2017/745 Annex I, Chapter III (Requirements regarding the information supplied with the device)
- ISO 15223-1 (Symbols to be used with medical device labels, labelling and information to be supplied)
- IEC 62366-1 (Application of usability engineering to medical devices)
Labeling Requirements
LR-4XK
Read the Instructions for Use before operating the device
Location:
Category: General Safety
Mitigates Risks: R-2TP, R-HBD, R-BDR, R-75H, R-DAG, R-SKK, R-2S3, R-L38, R-O5Y, R-G3V
The label and device output shall include a statement instructing users to read the Instructions for Use before operating the medical device. This is implemented via:
- The 'Consult instructions for use' symbol (ISO 15223-1) on the label
- The eIFU field in the device JSON output containing the text 'Read the instructions before use' and the IFU URL
This ensures users are directed to the complete Instructions for Use for proper device operation.
LR-7MN
Intended purpose and device description
Location:
Category: Intended Use, Regulatory
Mitigates Risks: R-TLM, R-ZFR, R-CGQ, R-8KS, R-2S3, R-L38, R-O5Y
The IFU shall clearly specify the intended purpose of the device, including:
- The device is intended to support healthcare professionals in the diagnosis and follow-up of skin conditions
- The device analyzes images of skin structures (epidermis, dermis, and appendages)
- The device outputs an interpretative probability distribution of possible ICD categories
- The device is intended for use by qualified healthcare professionals (HCPs) and IT professionals (ITPs)
- The device outputs are intended to support, not replace, clinical judgment
LR-2PQ
Intended user profile and qualifications
Location:
Category: Intended User, Regulatory
Mitigates Risks: R-TLM, R-4GG, R-ZFR, R-CYO, R-2S3, R-L38
The IFU shall specify the intended user profile and required qualifications:
- Healthcare Professionals (HCPs): Any healthcare professional who, by virtue of their academic degree, professional license, or recognized qualification, is authorized to provide healthcare services. This includes physicians (not necessarily trained in clinical diagnosis of skin diseases), nurses, and other licensed practitioners who will interpret device outputs.
- IT Professionals (ITPs): Technical personnel with expertise in API integration, software development, and healthcare IT systems who will integrate the device.
Both user groups must have appropriate authorization within their healthcare organization.
LR-9WR
Device outputs interpretation guidance
Location:
Category: Clinical Safety, Output Interpretation
Mitigates Risks: R-HBD, R-BDR, R-75H, R-DAG, R-SKK, R-HAX, R-G3V
The IFU shall provide comprehensive guidance on interpreting device outputs, including:
- Explanation of the probability distribution format for ICD categories
- Description of each clinical indicator (malignancy, pigmented lesion, urgent referral, high priority referral, has condition)
- Interpretation of the entropy score and its meaning for diagnostic confidence
- Explanation of explainability media (heat maps) and their clinical relevance
- Clear statement that outputs support clinical decision-making but do not replace professional judgment
LR-5TG
API integration instructions
Location:
Category: Integration, Technical
Mitigates Risks: R-2TP, R-HBD, R-BDR, R-CYO, R-UK2, R-U6M
The IFU shall include comprehensive API integration instructions for ITPs, including:
- REST API architecture overview and FHIR standard compliance
- JWT-based authentication process using time-limited access tokens
- Endpoint documentation with request/response formats (embedded interactive documentation)
- JSON data interchange format specifications
- HTTP status codes and error handling guidance
- Base URL and endpoint path conventions
LR-8HV
Minimum user interface requirements
Location:
Category: User Interface, Integration
Mitigates Risks: R-BDR, R-HAX, R-UK2
The IFU shall specify the minimum requirements for the user interface that ITPs must implement when presenting device outputs to HCPs. This includes:
- Display of the complete probability distribution, not just the top result
- Clear presentation of all clinical indicators
- Display of explainability media (heat maps) when available
- Presentation of metadata including software version and analysis timestamp
- Warning messages and quality indicators must be prominently displayed
These requirements ensure consistent and safe presentation of device outputs across different healthcare systems.
LR-3FK
How to take pictures - Image capture guidelines
Location:
Category: Image Capture, Usability
Mitigates Risks: R-AGQ, R-E7Z, R-TA9, R-5L4, R-UK2, R-K6L, R-RAJ
The IFU shall include a dedicated section on how to capture optimal images for device analysis, including:
- Lighting requirements: adequate, even lighting without harsh shadows or reflections
- Camera positioning: perpendicular to the skin surface at appropriate distance
- Focus requirements: skin structure must be in sharp focus
- Image resolution: minimum requirements for acceptable image quality
- Background considerations: neutral background preferred
- Multiple image guidance: when to capture multiple views
- Common issues to avoid: motion blur, glare, partial obstruction
LR-6NJ
Technical specifications - Camera requirements
Location:
Category: Technical Specifications, Hardware
Mitigates Risks: R-TA9, R-G3V
The IFU shall specify the technical requirements for image capture devices:
- Minimum camera resolution requirements
- Supported image formats (JPEG, PNG)
- Maximum and minimum file sizes
- Color depth requirements
- Recommended camera settings
- List of tested and validated camera types/devices
LR-1YB
Security requirements and recommendations
Location:
Category: Cybersecurity, Integration
Mitigates Risks: R-D1I, R-TLM, R-4GG, R-3YJ, R-UI5
The IFU shall include a dedicated section on security requirements and recommendations for ITPs, including:
- API token management and secure storage (JWT tokens with expiration)
- Network security requirements (HTTPS/TLS 1.2+ encryption)
- Authentication best practices
- Role-based access control implementation guidance
- Data protection and privacy requirements
- Audit logging and monitoring recommendations
- Regular security assessment recommendations
LR-4RZ
Warnings and precautions
Location:
Category: Clinical Safety, Warnings
Mitigates Risks: R-DAG, R-SKK, R-8KS
The IFU shall include warnings and precautions based on residual risk analysis:
Warnings:
- Device outputs are intended to support, not replace, clinical judgment
- Results should always be validated by a qualified HCP considering medical history and symptoms not visible to the device
- Review explainability media and metadata returned by the device
Precautions:
- Follow the 'How to take pictures' guidelines for optimal image quality
- Pay attention to image quality information in device output
- Refer to the Installation Manual for integration guidance
- Use flash when lighting conditions are suboptimal
- Training is available upon request to improve imaging process
LR-0CD
Contraindications
Location:
Category: Contraindications, Clinical Safety
Mitigates Risks: R-E7Z, R-8KS, R-X93
The IFU shall clearly state contraindications for device use:
- Do not use the device for skin structures that are not accessible by camera (e.g., located in skin folds or otherwise covered)
- Do not use for non-dermatological images
- Do not use as the sole basis for treatment decisions without HCP review
- Do not use when image quality score indicates insufficient quality
- Do not use for conditions outside the validated ICD categories
LR-2WM
ICD classification system information
Location:
Category: Clinical, Interoperability
Mitigates Risks: R-A96
The IFU shall provide information about the ICD classification system used by the device:
- The device uses ICD-11 classification codes
- Explanation of how ICD-11 codes are structured in the device output
- List of ICD-11 categories related to specific clinical indicators (e.g., malignancy categories)
- Guidance on interpreting the probability distribution across ICD-11 categories
LR-7XP
HL7 FHIR interoperability standard compliance
Location:
Category: Interoperability, Standards
Mitigates Risks: R-2TP, R-HBD, R-U6M
The IFU shall document the device's compliance with HL7 FHIR interoperability standards:
- The device outputs follow FHIR specifications, returning a DiagnosticReport resource
- DiagnosticReport status is marked as 'preliminary' to indicate outputs support, not replace, clinical judgment
- FHIR-compliant data format for healthcare system integration
LR-9KT
Software version identification
Location:
Category: Traceability, Regulatory
Mitigates Risks: R-TBN, R-4Z5
The IFU and label shall include:
- Current software version number
- Version identification format explanation
- How to verify the software version being used
- Notification process for new version releases
- Backward compatibility information
LR-5DP
Device lifetime and end-of-support information
Location:
Category: Lifecycle, Regulatory
Mitigates Risks: R-3OG
The IFU shall specify the expected device lifetime:
- Device operational lifetime: 5 years from release date
- End-of-support notification procedures
- Migration guidance when approaching end-of-life
- Historical version support information
LR-8MQ
Maintenance information - No user maintenance required
Location:
Category: Maintenance, Operational
Mitigates Risks: R-046, R-7GC
The IFU shall clearly state that:
- The device does not require any maintenance activities by users
- The device does not require performance checks by users
- Software updates are managed by the manufacturer
- Users will be notified when new versions are available
- Process for transitioning to new software versions
LR-6JL
Error messages and troubleshooting
Location:
Category: Troubleshooting, Support
Mitigates Risks: Not specified
The IFU shall include guidance on error messages and troubleshooting:
- List of common error codes and their meanings
- Troubleshooting steps for connectivity issues
- Guidance on image quality error messages
- Contact information for technical support
- Escalation procedures for persistent issues
LR-3BN
Clinical benefits information
Location:
Category: Clinical, Regulatory
Mitigates Risks: R-1OC
The IFU shall include information about the clinical benefits of the device:
- Description of demonstrated clinical benefits
- Summary of clinical validation studies
- Performance metrics (sensitivity, specificity where applicable)
- Limitations and scope of clinical benefits
- References to clinical evaluation documentation
LR-1RH
eIFU accessibility information
Location:
Category: Accessibility, Regulatory
Mitigates Risks: R-GTY, R-109, R-BXD, R-ZNA, R-EZZ
The IFU shall include information about accessing electronic instructions:
- URL for accessing the electronic IFU
- Browser compatibility requirements (any modern browser)
- Operating system compatibility (any OS with web browser)
- PDF download availability
- Process for requesting paper copy of IFU
- Contact information for IFU requests
LR-4KV
Manufacturer identification and contact information
Location:
Category: Regulatory, Identification
Mitigates Risks: R-TBN, R-4Z5
The label and IFU shall include complete manufacturer identification:
- Manufacturer name and address
- Contact information for technical support
- Contact information for adverse event reporting
- Regulatory representative information where applicable
- Website URL
LR-2GT
Regulatory compliance symbols and CE marking
Location:
Category: Regulatory, Labeling
Mitigates Risks: R-TBN
The label shall include all required regulatory symbols according to ISO 15223-1:
- CE marking with notified body number
- Manufacturer symbol
- Date of manufacture
- Unique Device Identifier (UDI)
- Consult instructions for use symbol
- Medical device symbol
- Software version indication
LR-8YN
Device supervision requirement statement
Location:
Category: Clinical Safety, Intended Use
Mitigates Risks: R-DAG, R-SKK, R-4GG, R-ZFR
The IFU and label shall prominently state that:
- The device must always be used under the supervision of a qualified healthcare professional (HCP)
- Device outputs are intended to support clinical decision-making, not replace it
- The HCP should confirm or validate the output considering the patient's medical history and other symptoms not visible or supplied to the device
- Final diagnostic and treatment decisions remain the responsibility of the supervising HCP
LR-5XM
Image quality feedback interpretation
Location:
Category: Image Quality, Usability
Mitigates Risks: R-AGQ, R-E7Z, R-TA9, R-5L4, R-X93, R-K6L, R-RAJ
The IFU shall explain how to interpret image quality feedback from the device:
- Description of the image quality scoring system
- Threshold values for acceptable image quality
- Guidance on improving image quality when scores are low
- Relationship between image quality and result reliability
- When to discard and retake images
LR-0VP
Data privacy and protection statement
Location:
Category: Data Privacy, Regulatory
Mitigates Risks: R-D1I, R-3YJ
The IFU shall include information about data privacy and protection:
- Types of data processed by the device (images, clinical analysis)
- Data encryption measures (HTTPS/TLS for transmission, encrypted storage recommendations)
- User responsibilities for patient data protection and implementing data retention policies
- Guidance on role-based access control and audit logging for compliance
LR-7QW
Training availability statement
Location:
Category: Training, Support
Mitigates Risks: R-AGQ, R-E7Z, R-TA9, R-5L4, R-K6L, R-RAJ
The IFU shall include information about available training:
- Statement that training is offered to users to improve the imaging process for optimal device operation
- Instructions to request training through the closest sales representative
LR-6HS
REST API protocol
Location:
Category: Technical, Integration
Mitigates Risks: R-U6M
The IFU shall document the REST API protocol used by the device:
- Device operates via REST API endpoints
- JSON-based request and response format
- Secure API communications via HTTPS
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
- Approver: JD-001 General Manager