MDR GSPR checklist builder
Tell us about your device, and we filter the 23 General Safety and Performance Requirements of MDR Annex I. Mark applicability, map standards and evidence, and track status.
A working aid, not a completed GSPR checklist. Each requirement has sub-sections, and standards must be checked for applicability and the current harmonised version. Non-applicability must be justified in your technical documentation. Your data stays in your browser.
MDR GSPR checklist builder
Device characteristics
| GSPR | Requirement | Applicable | Standards / common specifications, or justification | Evidence (document reference) | Status |
|---|
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Source: Regulation (EU) 2017/745, Annex I. EUR-Lex ↗
Want your GSPR checklist done properly?
Our MDR Transition Support package includes a complete, sub-section level GSPR checklist mapped to standards and evidence in your technical documentation, ready for notified body review.
FAQ
How many GSPRs are there in MDR Annex I?
Annex I contains 23 General Safety and Performance Requirements in three chapters: general requirements (1–9), design and manufacture (10–22) and information supplied with the device (23). Most have several sub-sections.
Can a GSPR be marked not applicable?
Yes, but the reason must be justified in the technical documentation. Requirements 1–8 apply to every device.
Do we have to use harmonised standards?
No, but conformity with harmonised standards published in the Official Journal gives a presumption of conformity with the requirements they cover. Common specifications, where they exist, must be followed or an equivalent level of safety demonstrated.