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 all requirements of EU IVDR 2017/746 with our comprehensive Technical Documentation 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 IVD manufacturers efficiently compile and organise all necessary documentation, reducing compliance risks and regulatory delays while providing a clear path to conformity assessment.
Key Features
Key Features
✔ Pre-Formatted Technical Documentation Structure - Covers all Annex II & III IVDR requirements with integrated checklists.
✔ Device Description & Specification Section - Clearly document product details, intended purpose, and performance characteristics.
✔ GSPR Compliance Checklist - Comprehensive framework for demonstrating alignment with Annex I requirements.
✔ Risk Management Documentation - Integration with ISO 14971 risk management file requirements.
✔ Performance Evaluation Plan - Structured approach for documenting scientific validity, analytical and clinical performance.
✔ Manufacturing & Quality Documentation - Templates for demonstrating ISO 13485 compliance and production controls.
✔ Labelling & UDI Compliance Sections - Ensures conformity with EU labelling requirements and unique device identification.
✔ Post-Market Surveillance Plan - Framework for ongoing monitoring and PMPF requirements.
✔ Editable Digital Format - Fully customisable for different IVD risk classifications (A-D).
Why choose a QMS Template?
Why choose a QMS Template?
This IVDR Technical Documentation Template is specifically designed for IVD manufacturers, regulatory affairs teams, and consultants to streamline documentation preparation, ensuring faster, audit-ready compliance with EU requirements.
The template includes expert guidance notes and cross-references to relevant MDCG guidance documents to support proper implementation.
Download the EU IVDR Technical Documentation Template today and simplify your path to regulatory compliance and market access!
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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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