WHY CE-IVDR MATTERS FOR YOUR LABORATORY

Understanding the critical regulatory deadline that's reshaping diagnostic software compliance across Europe and the UK

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WHAT HAPPENED ON MAY 26, 2025?

The In Vitro Diagnostic Regulation (IVDR) fully replaced the older IVDD directive, creating immediate compliance requirements for all diagnostic software used in clinical laboratories in the EU and UK.         

BEFORE MAY 26, 2025

• Software could be self-certified under IVDD

• Less stringent clinical evidence requirements

• Simpler quality management systems

• Limited post-market surveillance

AFTER MAY 26, 2025

• CE-IVDR certification required for all diagnostic software

• Enhanced clinical evidence and performance evaluation

• Comprehensive Quality Management System integration

• Strengthened post-market surveillance requirements

IMMEDIATE ACTIONS REQUIRED

1. Contact vendors for certification documentation

2. Develop transition plan for non-compliant systems

3. Update quality management system procedures

4. Implement compliant solutions before audit exposure

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The PCR.AI AI API (engine) is CE-IVDR certified and MHRA registered, providing laboratories and manufacturers with a future-proof solution that eliminates regulatory uncertainty.

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