Software & Usability — EU MDR Related Standards
Official Source: EC Health — Harmonised Standards | Based on CID (EU) 2021/1182 (consolidated) and amendment CID (EU) 2026/193
Widely-Used Standards (Non-Harmonised)
| Standard | Title Summary | GSPR Reference | Status |
|---|---|---|---|
| EN IEC 62304:2006+A1:2015 | Software life cycle processes | GSPR 17, 5 (Software & usability) | Widely used (non-harmonised) |
| EN IEC 62366-1:2015+A1:2020 | Application of usability engineering to medical devices | GSPR 17, 5 (Software & usability) | Widely used (non-harmonised) |
Important: EN IEC 62304 and EN IEC 62366-1 are not on the EU MDR harmonised standards list (CID 2021/1182). They do not create a presumption of conformity, but are industry-accepted methods for demonstrating GSPR 17 (software) and GSPR 5 (usability) compliance and must be justified as "other methods" in the technical file.
EN IEC 62304 — Software Safety Classification
| Safety Class | Definition | Requirements Level |
|---|---|---|
| Class A | No contribution to hazardous situation | Basic requirements |
| Class B | Non-serious injury possible | Moderate requirements |
| Class C | Death or serious injury possible | Full requirements |
EN IEC 62366-1 — Usability Engineering Process
- Use specification: users, use environment, user interface
- User interface specification: UI design requirements
- Summative usability evaluation: testing with representative users
- Usability engineering summary report