Latest News: Aiosyn expands AI-powered quality control with incomplete scan detection Learn more

Blog

Navigating the IVDR: How Aiosyn prioritized compliance from day one

By Diana Rosentul
26 May, 2025

Key takeaways

  • IVDR represents a significant overhaul of regulations requiring more rigorous oversight, clinical validation assessed by a Notified Body, and stricter post-market surveillance (PMS).
  • Aiosyn’s AI-powered solution for mitotic figure counting was built from the ground up to comply with IVDR’s highest regulatory standards rather than transitioning from the superseded IVDD.
  • Aiosyn avoided the transition period and potential delays by being IVDR-compliant from the start, ensuring smoother market access and increased credibility.
  • By raising the bar for technical documentation, PMS, and clinical performance evaluation, IVDR creates greater confidence in diagnostic tools for pathologists and clinicians.
  • IVDR is ultimately about patient safety and ensuring the reliability and safety of medical devices.

 

 

Introduction

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.

 

The IVDD to IVDR shift: more than just compliance

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:

  • Notified body oversight – Over 80% of IVD devices now require assessment by a notified body.
  • Stronger clinical evidence requirements – Clinical performance studies are now mandatory and post-market surveillance (PMS) is more strict.
  • EUDAMED & UDI implementation – Enhanced traceability of devices across the EU.
  • Harmonized regulation across member states – Unlike IVDD (a directive that allowed national interpretation), IVDR is a regulation, meaning it applies uniformly across all EU countries.

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.

 

Why Aiosyn did not need a transition period

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:

  • Regulatory rigor from the outset – No shortcuts, no retroactive adjustments.
  • Future-proof compliance – While others adapt, we are already aligned with the regulatory landscape.
  • Stronger market positioning – Having an IVDR-compliant product early ensures smoother market access and increased credibility.

 

Advancing pathology with AI-powered mitotic figure counting

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.

 

What this shift means for the industry

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.

  • For regulatory professionals: IVDR significantly raises the bar for technical documentation, PMS, and clinical performance evaluation. Companies delaying the IVDR transition risk being caught in the notified body bottleneck. Notified Bodies are doing their best to process all our submissions (either directly to the IVDR or as legacy devices transitioning from the IVDD), but they are working at capacity and waiting times are to be expected.
  • For pathologists and clinicians: A more stringent regulatory framework means greater confidence in diagnostic tools. IVDR ensures that AI-driven solutions meet the highest standards of reliability and safety.
  • For IVD manufacturers: Transitioning to IVDR is not just about meeting a deadline—it is about future-proofing innovations. The sooner companies move beyond IVDD-era practices, the better positioned they will be for global regulatory convergence.

 

A personal perspective on IVDR— Diana Rosentul, Regulatory Affairs Specialist at Aiosyn

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.