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A detailed practitioner-developed MDR / IVDR GSPR Compliance Matrix designed to help manufacturers map each applicable General Safety and Performance Requirement to the method of conformity and the objective evidence that supports it.
The template includes:
• MDR and IVDR Annex I requirement mapping
• Applicability and device-specific rationale fields
• Method of conformity and standards / common-specification references
• Objective evidence references by document, revision and section
• Status tracking and remediation fields
• Evidence sufficiency review
• Gap and action tracker
Suitable for use during Technical Documentation preparation, remediation, internal review and submission readiness activities.
Format: Editable Microsoft Word document.
Important: This template is a structured regulatory starting point and must be adapted to the specific manufacturer, device, intended purpose, classification, target markets and applicable regulatory requirements. It does not by itself demonstrate conformity.
A detailed practitioner-developed MDR / IVDR GSPR Compliance Matrix designed to help manufacturers map each applicable General Safety and Performance Requirement to the method of conformity and the objective evidence that supports it.
The template includes:
• MDR and IVDR Annex I requirement mapping
• Applicability and device-specific rationale fields
• Method of conformity and standards / common-specification references
• Objective evidence references by document, revision and section
• Status tracking and remediation fields
• Evidence sufficiency review
• Gap and action tracker
Suitable for use during Technical Documentation preparation, remediation, internal review and submission readiness activities.
Format: Editable Microsoft Word document.
Important: This template is a structured regulatory starting point and must be adapted to the specific manufacturer, device, intended purpose, classification, target markets and applicable regulatory requirements. It does not by itself demonstrate conformity.