GSPR Checklist Template - IVDR 2017/746 ISO 9001 Procedure What’s Included in the Bundle

What’s Included in the Bundle

Set Actions and Reviews: Document the actions taken and the reviews conducted to ensure effectiveness

The Declaration of Conformity is required to be uploaded onto the EUDAMED system for EU market access

and Resources: Identifying necessary procedures

then this part of the standard is not applicable

GSPR Checklist Template - IVDR 2017/746 ISO 9001 Procedure What’s Included in the BundleGeneral Safety & Performance Requirements (GSPR) Checklist Template IVDR 2017 746 The General Safety and Performance Requirements (GSPR) checklist is a checklist against Annex I of the In Vitro Diagnostic Device Regulations (IVDR) EU 2017 746. The device needs to be assessed against each clause of annex I, and evidence presented on how the requirements has been met and where the evidence is located, or a justification as to why the requirement is not