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GSPR Checklist

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.
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Checklist: MDR General Safety and Performance Requirements

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1. Purpose

The purpose of this document is to define the scope of general safety and performance requirements (GSPRs) that apply to the device and to provide evidence for conformity and rationale for any deviations.

2. Scope

This document applies to Vestibulum ante ipsum primis in faucibus orci luctus et ultrices posuere cubilia Curae; and its access to the European Union market where the MDR 2017/745 GSPRs are applicable.

3. Documentation Group References

A full list of references for which standards and regulations apply to Etiam cursus, sapien nec varius dictum, justo erat faucibus urna, nec dictum erat erat ut massa. can be found in the List of Regulatory References document.

4. Standards and Regulatory References

A full list of references for which standards and regulations apply to Quisque sed velit euismod, dictum massa eu, suscipit enim. can be found in the List of Regulatory References document.

5. GSPR Chapters

Chapter I: General Requirements

Content omitted for brevity.

Chapter II: Requirements Regarding Design and Manufacture

Content omitted for brevity.

Chapter III: Requirements Regarding the Information Supplied with the Device

Content omitted for brevity.