Pavia, Italy – enGenome today announced that eVai, its AI-driven variant interpretation platform, has achieved IVDR certification as a Class C medical device, reinforcing its regulatory readiness for clinical use across the European Union. The In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) sets high standards for clinical software used in diagnostic workflows, with a strong focus on safety, performance, and traceability. Achieving IVDR certification confirms that eVai meets these requirements and is suitable for use in regulated clinical environments across the European Union.
This certification builds on eVai’s existing CE-IVD marking, further strengthening its alignment with current European regulatory requirements.
As genomic testing continues to scale, laboratories face increasing pressure to deliver accurate and consistent interpretations while managing growing data volumes. IVDR certification reinforces enGenome’s focus on building tools that can be trusted in routine clinical practice, supporting laboratories as they integrate AI-assisted interpretation into their workflows.
