GSPR Checklist Template - IVDR 2017/746
GSPR Checklist Template - IVDR 2017/746
Template Overview
Template Overview
Ensure your In Vitro Diagnostic (IVD) devices comply with the EU In Vitro Diagnostic Regulation (IVDR) 2017/746 using our GSPR Checklist Template. The General Safety and Performance Requirements (GSPR) are a critical part of IVDR compliance, requiring manufacturers to demonstrate their device meets essential safety, performance, and risk management criteria before placing it on the EU market.
Key Features
Key Features
✓ Pre-Formatted Checklist – Covers all Annex I GSPR requirements under IVDR.
✓ Structured Compliance Sections – Easily document conformity with applicable requirements.
✓ Reference to Harmonized Standards & Common Specifications – Align evidence with IVDR expectations.
✓ Risk Management & Performance Evaluation Links – Ensure integration with ISO 14971 & scientific validity.
✓ Editable Digital Format – Fully customizable for different IVD classifications.
✓ GAP Analysis Functionality – Identify missing documentation for compliance readiness.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use IVDR GSPR Checklist Template is designed for manufacturers, regulatory consultants, and quality teams to streamline the technical documentation process. It saves time, ensures consistency, and supports a structured approach to EU compliance.
Get your IVDR GSPR Checklist Template today and confidently prepare your Technical Documentation for IVDR compliance!
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About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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