Building Your IVDR Technical Documentation: A Step-by-Step Guide

Technical documentation is the foundation of IVDR compliance. This guide walks through the essential components and best practices for creating robust documentation.

Annex II Requirements Overview

The Technical Documentation requirements in Annex II cover:

• Device description and specification
• Information to be supplied by the manufacturer
• Design and manufacturing information
• General safety and performance requirements
• Risk-benefit analysis and risk management
• Product verification and validation

Device Description Section

Your device description should include:

• Product and trade names
• Intended purpose with clear clinical context
• Indication for use and target population
• Principles of operation
• Risk classification with justification
• Any novel features requiring special consideration

Design and Manufacturing Documentation

This section requires detailed documentation of:

• Design history and development records
• Manufacturing process descriptions
• Critical suppliers and materials
• Environmental conditions
• Quality control measures

GSPR Compliance Evidence

Document how each applicable GSPR from Annex I is addressed, including references to standards, test reports, and design controls.

Documentation Management Tips

• Use a document management system with version control
• Maintain a Technical Documentation index for easy navigation
• Ensure traceability throughout all documents
• Plan for periodic updates based on PMS data