AI-Driven Software in IVDs

Navigating SaMD Under the IVDR Today and Tomorrow

What Manufacturers Need to Know About AI-Driven Software in IVDs

Software now powers diagnostic analysis, but AI brings new regulatory expectations. Here are the key points for manufacturers working under the IVDR.

Software has moved from a supporting tool to the engine behind IVD analysis and clinical decisions.
The IVDR treats software as a medical device (SaMD), bringing greater scrutiny across the lifecycle.
AI algorithms need transparency, representative training data, and robust change control.
Cybersecurity and interoperability are essential for safe use in laboratory and clinical settings.
Digital pathology, sequencing bioinformatics, and near-patient testing are leading AI use cases.
The EU AI Act and AI Digital Omnibus mean manufacturers should plan for dual compliance.