Resources & Blog

Expert insights, guides, and regulatory updates to support your IVDR compliance journey.

IVDR Transitional Provisions: Timeline and Strategy Planning

Navigate the extended IVDR transition periods with this comprehensive timeline guide and strategic planning recommendations.

IVDR.net Team6 min

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IVDR Fundamentals

Understanding IVDR Device Classification: A Practical Approach

Navigate the IVDR classification rules with this practical guide, including examples for common IVD device types and tips for borderline cases.

IVDR.net Team9 min

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Performance Evaluation

IVDR Performance Evaluation: From Planning to Reporting

Complete guide to planning and executing performance evaluation studies under IVDR, covering scientific validity, analytical performance, and clinical performance requirements.

IVDR.net Team12 min

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Technical Documentation

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

Detailed walkthrough of creating compliant technical documentation per IVDR Annexes II and III, with practical tips for efficient documentation development.

IVDR.net Team10 min

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Notified Body Insights

Preparing for Your First IVDR Notified Body Audit

Practical guidance on preparing for Notified Body certification audits under IVDR, including common audit findings and how to avoid them.

IVDR.net Team7 min

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IVDR Fundamentals

IVDR vs IVDD: Understanding the Key Differences

A comprehensive comparison between the new In Vitro Diagnostic Regulation (IVDR) and the former IVD Directive (IVDD), highlighting the most significant changes affecting manufacturers.

IVDR.net Team8 min

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