GSPR Checklist Approach
Overview
A GSPR compliance matrix maps every applicable MedDO Annex I requirement to the evidence of compliance. It is a mandatory element of technical documentation and will be reviewed by the notified body and/or Swissmedic.
Compliance Matrix Columns
| Column | Content |
|---|---|
| GSPR Reference | Specific Annex I section (e.g. "Chapter II, § 10.3") |
| Requirement Summary | Plain-English description of the requirement |
| Applicability | Applicable / Not Applicable + justification |
| Method of Compliance | Standard, common specification, or other technical solution |
| Standard / Document Reference | Specific standard or test report |
| Evidence Location | Where in the technical file the evidence can be found |
| Status | Compliant / Non-compliant / In progress |
Handling Non-Applicable Requirements
Every non-applicable GSPR must include a device-specific justification. "Not applicable to this type of device" is insufficient — the justification must be specific to this device's design, materials, and intended use.
Gap Analysis Before NB Submission
Before submitting to an NB, conduct a gap analysis to identify: GSPRs with incomplete testing; outdated standard references; requirements addressed only by internal documents without external validation; device-specific requirements overlooked.
Official Sources
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.