Annex I — General Safety and Performance Requirements (GSPR)
Source: EU MDR 2017/745 Annex I | OJ L 117, 5.5.2017
Part I — General Requirements (GSPR 1–9)
| GSPR | Requirement Summary |
|---|---|
| GSPR 1 | Devices shall achieve their intended purpose and not compromise the clinical condition or safety of patients |
| GSPR 2 | Risks shall be reduced as far as possible (AFAP); benefits shall outweigh residual risks |
| GSPR 3 | Manufacturers shall establish, implement, document and maintain a risk management system (see EN ISO 14971) |
| GSPR 4 | Devices shall perform as intended under normal conditions of use |
| GSPR 5 | Devices shall be designed and manufactured in accordance with the state of the art |
| GSPR 6 | Benefits shall outweigh risks (benefit-risk analysis) |
| GSPR 7 | Known and foreseeable risks shall be reduced as far as possible |
| GSPR 8 | Devices shall perform in accordance with the manufacturer's intended purpose |
| GSPR 9 | For devices with a diagnostic or measuring function, accuracy shall be ensured |
Part II — Requirements for Design and Manufacture (GSPR 10–22)
| GSPR | Requirement Summary | Key Harmonised Standards |
|---|---|---|
| GSPR 10 | Chemical, physical and biological properties | EN ISO 10993 series |
| GSPR 11 | Infection and microbial contamination | EN ISO 11135, 11607 series |
| GSPR 12 | Devices containing substances or materials | EN ISO 10993-1 |
| GSPR 13 | Interaction with the environment and other devices | — |
| GSPR 14 | Electrical safety and electromagnetic compatibility | EN IEC 60601 series |
| GSPR 15 | Protection against mechanical risks | — |
| GSPR 16 | Protection against radiation risks | — |
| GSPR 17 | Electronic programmable systems and software | EN IEC 62304 |
| GSPR 18 | Active devices and devices connected to them | EN IEC 60601-1 |
| GSPR 19 | Specific requirements (implantable devices) | — |
| GSPR 20 | Specific requirements (devices incorporating a medicinal substance) | — |
| GSPR 21 | Specific requirements (devices incorporating materials of human or animal origin) | — |
| GSPR 22 | Specific requirements (IVD devices) | — |
Part III — Requirements for Information Supplied with the Device (GSPR 23)
GSPR 23 — Label and Instructions for Use
Manufacturers shall provide:
- Label: device identification, intended purpose, manufacturer information, UDI, etc.
- Instructions for Use (IFU): all information necessary for safe use
Key harmonised standards: EN ISO 15223-1, EN ISO 20417
GSPR Applicability Analysis
In clinical evaluation and technical documentation, manufacturers shall:
- List all applicable GSPR clauses
- Describe the method used to demonstrate conformity with each GSPR (harmonised standard / common specification / other method)
- Provide evidence of conformity
Related Pages
- Harmonised Standards — Biocompatibility
- Harmonised Standards — Risk Management
- Harmonised Standards — Electrical Safety
- Harmonised Standards — Software
- Article 52 — Conformity Assessment Procedures