We have exciting news to share! Our variant interpretation platform, AION, is now officially CE-IVDR certified, becoming the first in its category with an AI component also certified under IVDR, setting a new standard for AI in genomics.
This milestone underscores our commitment to providing clinical diagnostic laboratories with a secure, compliant, and high-performance solution that meets the highest regulatory standards in genetic diagnostics.
CE-IVDR certification confirms that AION meets the rigorous European requirements for safety, performance, and reliability. This milestone reinforces AION’s position as a trusted and future-ready platform, providing you with a validated, seamlessly integrated solution that keeps pace with evolving regulatory frameworks.
The In Vitro Diagnostic Medical Device Regulation (IVDR, EU 2017/7461) is the European regulatory framework that governs all in vitro diagnostic medical devices, including software used in genetic testing. Introduced to replace the older IVDD directive from 19982, IVDR became fully applicable in May 2022, imposing stricter requirements to enhance the safety, performance, and reliability of diagnostic tools3. Recognizing the complexity of implementation, the regulation includes a transition period, allowing manufacturers time to achieve compliance. More recently, acknowledging the difficulties manufacturers face in meeting these requirements, the transition deadlines have been extended through Regulation (EU) 2024/1860, published on July 9, 20244,5.
However, while the extended deadlines provide some breathing room, at Nostos Genomics, we firmly believe that implementing IVDR should be a priority, regardless of regulatory timelines. Ensuring that medical devices meet the highest quality standards is essential to guaranteeing patient safety and high-quality care. Moreover, delaying compliance comes with risks—legacy devices have been effectively frozen in terms of design and intended purpose since May 2022, putting them at a disadvantage in an industry defined by rapid technological advancements and scientific discoveries, such as novel gene-disease associations. Transitioning to IVDR compliance not only ensures regulatory adherence but also unlocks opportunities for product evolution and innovation6.
Obtaining CE-IVDR certification before the mandatory transition deadline is a significant milestone that reflects our proactive approach to compliance. AION’s certification at this stage establishes it as a pioneering AI-driven variant interpretation platform in achieving IVDR compliance. This ensures that laboratories adopting AION stay ahead of the regulatory curve, avoiding disruptions and facilitating a seamless transition to fully compliant workflows.
At the core of our IVDR compliance journey is a shared mission to enhance patient care through precise and reliable genetic diagnostics. Genetic testing plays a critical role in clinical decision-making, and ensuring adherence to the highest regulatory standards translates to greater confidence in every test result.
By obtaining CE-IVDR certification, AION strengthens the integrity of genetic testing, ensuring that every analysis is performed with the highest level of confidence and accuracy. This, in turn, empowers healthcare professionals to make more informed, timely, and precise diagnoses, ultimately improving patient outcomes.
Regulatory compliance is not just about meeting standards—it is about ensuring quality and safety at every step of the diagnostic process. By prioritizing IVDR compliance, AION enables laboratories and clinicians to work with a robust, validated solution that supports better medical decisions and high-quality patient care.
As a leader in innovative, regulation-compliant solutions, we remain committed to empowering genetic laboratories with cutting-edge technology that meets evolving regulatory standards. This achievement is just one step in our journey, and we will continue to push the boundaries of genetic diagnostics to support better patient care, regulatory excellence, and scientific innovation.
Thank you for being part of this exciting journey with us!
To learn more about how our variant interpretation platform, AION, can support your mission to better patient care, schedule a free demo with one of our genomics experts today.
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