Module23 March 20263 min read
Module spotlight: Essential Requirements (GSPR)
The GSPR checklist is the heart of EU conformity. This module keeps each general safety and performance requirement mapped to your evidence.
By MoniDoseQMS Team
At the core of EU conformity is a checklist: the General Safety and Performance Requirements (GSPR). For each requirement, you must show how your device meets it and point to the evidence. This module keeps that mapping organised and current.
What you can do
- Map each GSPR to how your device meets it
- Link requirements to the evidence and documents that satisfy them
- Track which requirements apply and which do not, with rationale
- Keep the mapping audit- and submission-ready
Why it matters
EU MDR Annex I defines the GSPR, and the conformity case is built on demonstrating each one. A live mapping to evidence is exactly what a notified body reviews.