GSPR Checklist (IVDR)

IVDR reference: Annex I (General Safety and Performance Requirements)
BPG reference: Team-NB BPG-IVDR V2 (approx. p. 15)
Document code: AII-S4

Checklist structure

• [ ] Conformity demonstration for each applicable Annex I GSPR; sub-sections addressed independently
• [ ] Method(s) used to demonstrate conformity for each applicable GSPR
• [ ] Precise identity of controlled documents offering evidence, with location cross-references in the full TD
• [ ] List of applicable standards and CS; partial application / deviations justified (summary or gap analysis)
• [ ] Non-applicable GSPRs justified consistently with intended purpose / technology

Suggested columns

GSPR	Applicable?	Method	Standard/CS	Evidence location	Notes

Evidence neighbour (IVDR)

• [ ] Evidence points to PER / analytical & clinical performance / RM / V&V / labelling IFU, not an MDR CER

Reguverse notes

• Generate checklist from eu_ivdr Annex I data (IVDR clause numbers only)

Related pages

• Risk management
• Performance evaluation
• Verification & validation