GSPR Overview
Overview
The General Safety and Performance Requirements (GSPRs) in MedDO Annex I set the fundamental safety and performance standards every medical device must meet. They are identical in structure and substance to EU MDR Annex I. Demonstrating GSPR compliance is the central task in preparing technical documentation and is assessed by notified bodies during conformity assessment.
Annex I Structure
Chapter I — General Requirements (§§ 1–9) Overarching obligations including: devices must achieve intended performance without compromising safety; risk reduction priority order (inherently safe design → protective measures → safety information); risk management must follow a structured documented process (ISO 14971); clinical evidence requirements.
Chapter II — Requirements Regarding Design and Manufacture (§§ 10–22) Specific requirements for: chemical/physical/biological properties; infection and microbial contamination; mechanical properties; ionising radiation; active device requirements; software (§ 17 — see Software as a Medical Device); active implantable and combination device requirements.
Chapter III — Information Supplied With the Device (§§ 23–24) Labelling and instructions for use requirements — see Labelling Requirements.
Demonstrating GSPR Compliance
Manufacturers demonstrate compliance by: identifying all applicable GSPRs; mapping each GSPR to a harmonised standard or other technical solution; documenting the evidence; justifying any GSPR deemed not applicable. This process is documented in a GSPR compliance matrix — see GSPR Checklist Approach.
Key Harmonised Standards
| GSPR | Standard |
|---|---|
| §§ 1–9 Risk management | ISO 14971:2019 |
| § 10 Chemical/biological | ISO 10993 series |
| § 11 Infection | ISO 11135, EN ISO 11607 |
| § 14 Ionising radiation | IEC 60601-1-3 |
| § 17 Software | IEC 62304, IEC 62366-1 |
| §§ 23–24 Labelling | ISO 15223, EN ISO 7000 |
Official Sources
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