Technical File Template - IVDR (EU 2017/746)
Technical File Template - IVDR (EU 2017/746)
Template Overview
Template Overview
Ensure your In Vitro Diagnostic (IVD) devices meet the requirements of EU IVDR 2017/746 with our Technical File Template. The Technical Documentation is a mandatory component for market approval, demonstrating that your IVD device complies with General Safety and Performance Requirements (GSPR) and other IVDR obligations. Our structured template helps manufacturers efficiently compile and organize all necessary documentation, reducing compliance risks and delays.
Key Features
Key Features
✔ Pre-Formatted Technical File Structure – Covers all Annex II & III IVDR requirements.
✔ Device Description & Intended Purpose – Clearly document product details.
✔ GSPR Compliance Section – Align with Annex I requirements.
✔ Risk Management & Performance Evaluation Sections – Integrate ISO 14971 and scientific validity data.
✔ Manufacturing & Quality Documentation – Demonstrate ISO 13485 compliance.
✔ Labeling & UDI Compliance Sections – Ensure conformity with EU labelling requirements.
✔ Editable Digital Format – Fully customizable for different IVD classifications.
Why choose a QMS Template?
Why choose a QMS Template?
This IVDR Technical File Template is designed for manufacturers, regulatory teams, and consultants to streamline documentation preparation, ensuring faster, audit-ready compliance.
Download the EU IVDR Technical File Template today and simplify your path to compliance!
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Additional information
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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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For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.