R-TF-012-041 Software Classification 62304
Change history
Product: Legit Health Plus Version: 1.1.0.0
Software Safety Classification
This document establishes the software safety classification for Legit Health Plus according to IEC 62304:2006/A1:2015.
Applicable Standards and Guidance
| Standard/Guidance | Version | Relevance |
|---|---|---|
| IEC 62304 | 2006/A1:2015 | Software lifecycle processes - Safety classification (Section 4.3) |
| MDR 2017/745 | Annex VIII, Rule 11 | Medical device classification |
| MDCG 2019-11 | Rev.1 (June 2025) | Qualification and Classification of Software |
Classification Summary
| Classification Aspect | Value | Rationale |
|---|---|---|
| MDR Risk Class | Class IIb | Rule 11: Software intended to provide information for diagnosis (serious condition) |
| IEC 62304 Safety Class | Class B | No death or serious injury possible after considering external risk control measures |
IEC 62304 Classification Definitions
| Class | Definition per IEC 62304:2015 Section 4.3 |
|---|---|
| Class A | No injury or damage to health is possible |
| Class B | Non-serious injury is possible |
| Class C | Death or serious injury is possible |
Per MDR 2017/745 Article 2(65), serious injury means: life-threatening injury, permanent impairment of body function, or permanent damage to body structure.
Classification Flowchart (IEC 62304:2015 Section 4.3)
Classification Rationale
Step 1: Can software failure contribute to a hazardous situation?
Yes. Legit Health Plus provides diagnostic support for dermatological conditions. A software failure (incorrect analysis, system unavailability) could contribute to delayed or incorrect diagnosis.
Step 2: After external risk control measures, can death or serious injury occur?
No. The following external risk control measures prevent death or serious injury:
| External Risk Control Measure | How it prevents serious injury |
|---|---|
| Healthcare professional clinical oversight | HCP makes final diagnosis; software is decision support only |
| Alternative assessment methods available | Traditional clinical examination remains available |
| Device labeled for HCP use only | Trained professionals interpret results with clinical judgment |
| IFU documents limitations | Users understand device is not standalone diagnostic |
Conclusion
Per R-TF-013-002 Risk Management Record, the residual hazards after applying risk control measures do not result in death or serious injury (no permanent impairment, no life-threatening conditions). Therefore:
Software System Classification: Class B
Note on Software Failure Probability (IEC 62304:2015 Section 4.3)
IEC 62304:2006/A1:2015 states:
"Probability of a software failure shall be assumed to be 1."
This means for classification purposes, we assume the software will fail. However, this does not mean all software is Class C. The safety class is determined by the severity of harm that could result from a failure, after considering external risk control measures.
| IEC 62304 Principle | Meaning |
|---|---|
| Probability of failure = 1 | Assume software will fail when classifying |
| Classification based on severity | Look at worst-case harm after external mitigations |
| External measures reduce severity | HCP oversight, training, alternative methods |
Software Items Classification
Per IEC 62304 Section 4.3, software items inherit the system classification unless segregation is demonstrated.
| Item ID | Software Item | Can contribute to hazardous situation? | Class | Rationale |
|---|---|---|---|---|
| ITSW-001 | AI/ML image analysis algorithm | Yes | B | Core diagnostic function |
| ITSW-002 | Image quality assessment | Yes | B | Affects analysis reliability |
| ITSW-003 | API authentication module | No | A | Security only; does not affect clinical output |
| ITSW-004 | Data transmission layer | No | A | Transport only; does not modify clinical data |
| ITSW-005 | FHIR interoperability interface | Yes | B | Affects data integrity in clinical systems |
| ITSW-006 | User interface and output display | Yes | B | Affects interpretation of results |
| ITSW-007 | Infrastructure management | No | A | Availability only; does not affect clinical content |
Overall Software Classification: Class B
References
| Document | Description |
|---|---|
| IEC 62304:2006/A1:2015 | Software lifecycle processes |
| MDR 2017/745 | Medical device regulation |
| MDCG 2019-11 rev.1 | Software qualification and classification |
| R-TF-013-002 Risk management record | Hazard analysis and risk controls |
| R-TF-012-037 Labeling Requirements | IFU and labeling |
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