Systematically evaluate compliance with essential safety and performance requirements for EU market access.
Element | Content |
---|---|
Requirement | Devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their intended use. |
Applicable | Yes |
Applicable Standards | EN 62304:2006+A1:2015 IEC 82304-1:2016 EN ISO 14971:2019 |
Evidence of Conformity | Software Development and Maintenance Plan (DOC-001) Software Architecture Document (DOC-015) Software System Test Report (DOC-045) Risk Management File (DOC-008) |
Rationale for Deviations | No deviations |
Element | Content |
---|---|
Requirement | Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in Chapter I are fulfilled, with particular attention to choice of materials, toxicity, and flammability. |
Applicable | No |
Applicable Standards | N/A |
Evidence of Conformity | N/A |
Rationale for Deviations | The device is software-only and does not contain physical materials susceptible to toxicity, flammability, or other chemical and physical properties. |
What happens if I mark a GSPR as not applicable but a notified body disagrees?
How do I handle GSPRs that are partially applicable to my device?
Can I use non-harmonized standards as evidence of GSPR compliance?
How often should I update my GSPR checklist?
What if my software device has measuring functions?
How do I address cybersecurity requirements in the GSPR checklist?