Usability / Human Factors Engineering
MDR Reference: Annex II, Section 6.1.6; Annex I GSPRs 5, 19
BPG Rev.4 Reference: Section 6.1.6
Service Item ID: mdr_sec06_usability
Applicability: All medical devices (with varying depth based on risk profile)
Overview
Usability engineering ensures that medical devices can be used safely and effectively by the intended users in the intended use environment. It is a risk-driven process that identifies and mitigates use-related hazards through iterative design and evaluation.
Current Standard: IEC 62366-1:2015+A1:2020
The primary standard defines the usability engineering process for medical devices:
Harmonisation status: IEC 62366-1 is not harmonised under MDR as of 2026. Compliance must be independently justified. However, it is universally accepted as the state-of-the-art standard for usability engineering by Notified Bodies.
Supplementary Guidance
- IEC/TR 62366-2:2016: Guidance on applying IEC 62366-1
- MDCG 2024-10: Orphan devices guidance (includes usability considerations)
- EN 60601-1-6:2010+A1:2013+A2:2020: Usability for medical electrical equipment
Key Deliverables
| Document | Description |
|---|---|
| Use Specification | Intended users, patients, use environments, use scenarios |
| Use-related Risk Analysis | Hazard-related use scenarios, use errors, severity assessment |
| User Interface Specification | UI design requirements derived from use specification and risk analysis |
| Formative Evaluations | Iterative design reviews, expert reviews, early-stage user testing |
| Summative Evaluation (Validation) | Final human factors validation with representative users |
| Usability Engineering File | Complete record of the usability engineering process |
Process Overview (IEC 62366-1)
- Use specification: Define intended users, use environments, clinical workflow
- Use-related risk analysis: Identify hazard-related use scenarios and potential use errors
- User interface specification: Design requirements for the user interface
- User interface design: Implement design based on specifications
- Formative evaluation: Iterative testing to identify and fix usability issues
- Summative evaluation: Final validation with representative users and tasks
- Residual risk assessment: Evaluate remaining use-related risks
Summative Evaluation Essentials
- Representative users (number, demographics, experience level)
- Critical tasks selected based on risk analysis
- Simulated or actual use environment
- Pass/fail criteria defined before testing
- Use errors, close calls, and difficulties documented and analysed
- Root cause analysis for any critical task failures
GSPR Mapping
| GSPR | Requirement |
|---|---|
| 5 | Ergonomic design principles, user environment, user capabilities |
| 19 | IFU and labels: understandable by intended users |
Related Topics
- Design V&V -- Usability validation is part of design validation
- Software V&V -- Software UI usability
- Risk Management -- Use-related risk analysis feeds into the risk management file
- IVDR usability -- IVD regime notes (shared IEC 62366-1 process)
- MDR↔IVDR usability crosswalk -- GSPR / FDA / China special notes
- FDA HF structured summary (2026) -- CDRH guidance outline for critical-task validation