The transition from IVDD to IVDR is one of the most significant regulatory shifts in the European in vitro diagnostics (IVD) industry. While many digital pathology and AI providers are still scrambling to meet the stringent IVDR requirements, we at Aiosyn took a different path.
Our AI-powered solution for mitotic figure counting was developed after IVDR came into effect. Unlike companies transitioning from IVDD, we built our technology from the ground up to comply directly with IVDR’s highest regulatory standards.
For those unfamiliar with the full scope of IVDR (Regulation (EU) 2017/746), it is not just an update to IVDD but a fundamental regulatory overhaul. Unlike IVDD, which allowed manufacturers to self-certify many devices (depending on their risk classification), IVDR requires more rigorous oversight and clinical validation assessed by an external party (Notified Body). Key changes include:
The deadline for all IVDD legacy devices to operate under an IVDR-compliant Quality Management System (QMS) is 26 May 2025 (today). While some providers have transition extensions until 2029 (depending on risk classification), all IVD manufacturers must align with IVDR’s quality and post-market requirements well before then.
While many companies face challenges in transitioning from IVDD to IVDR, Aiosyn did not need to make that switch because we started with IVDR compliance from day one.
We designed our AI-powered solution for mitotic figure counting under IVDR standards, ensuring:
At Aiosyn, we specialize in AI-powered computational pathology solutions that enhance diagnostic accuracy and efficiency. One of our key innovations is Aiosyn Mitosis Breast, our application for mitotic figure counting. Counting mitoses is a critical step in cancer diagnostics, helping pathologists assess tumor proliferation. By automating their detection with AI-driven precision, we reduce variability, improve consistency, and support pathologists in delivering more reliable and objective diagnoses.
Since mitotic figure counting is a crucial component of cancer grading, ensuring the safety and performance of such a tool is essential. That is why we designed our solution to meet IVDR’s rigorous requirements from the start, ensuring regulatory compliance while driving meaningful innovation in pathology.
Figure 1. Illustration depicting the Aiosyn Mitosis Breast AI-powered solution. Cells marked in green denote instances of mitotic figures.
For stakeholders across the IVD and pathology sectors, IVDR is more than a regulatory requirement—it is reshaping the entire competitive landscape by setting higher standards for diagnostic tools.
Regulation can sometimes feel like just another hurdle, but at its core, IVDR is about patient safety and trust.
As someone who may one day be a patient—and as a family member of people living in the EU—it gives me real confidence to know that the medical devices we rely on (including IVDs) have been proven to be safe and perform well. These regulations aren’t just for companies; they’re for all of us who depend on accurate diagnoses and effective treatments.
At Aiosyn, we take this responsibility seriously. Compliance isn’t just a checkbox—it’s a commitment to delivering the highest-quality solutions to clinicians and patients alike.
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