GSPR Checklist
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Use this MDR General Safety and Performance Requirements (GSPR) checklist template to systematically demonstrate and document your medical device’s compliance with all applicable EU MDR 2017/745 Annex I requirements. This comprehensive tool guides you in mapping each GSPR to applicable standards, evidence of conformity, and justifications for any deviations, ensuring you address safety, performance, usability, risk management, and labeling requirements. Complete this checklist during CE marking preparation or significant design changes to support your technical documentation and facilitate a smooth conformity assessment with Notified Bodies.