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 structurally and substantively aligned with EU MDR Annex I; Switzerland has independently adopted these requirements under MedDO. 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 60601-2-2 (or other relevant IEC 60601 part depending on device type) or equivalent standards for ionising radiation safety |
| § 17 Software | IEC 62304, IEC 62366-1 |
| §§ 23–24 Labelling | ISO 15223, EN ISO 7000 |