The IVDR Transition Is Not Over: Key Deadlines and Common Pitfalls

The core shift, as a reminder. IVDR (EU) 2017/746 replaced the former IVD Directive's largely self-certified system with a risk-based one. Under the Directive 98/79/EC (IVDD), roughly 80% of in vitro diagnostic medical devices were self-certified and did not require Notified Body review. Under the IVDR, that ratio has flipped — 80% of devices now do. That single change is the root of nearly all transition headaches that IVD manufacturers have faced: capacity bottlenecks, long review queues, and building technical documentation and QMS structures that were never previously required.

Where the IVDR transitional periods stand. The original deadlines proved unworkable; hence the EU Commission extended them via Regulation (EU) 2024/1860 — but the extension only applies if specific conditions are met; it is not automatic. IVD manufacturers only keep their extended market access if they hit the interim milestones for their device class:

· All device classes: IVDR-compliant Quality Management System (QMS) in place as of 26 May 2025.

· Class D: Notified Body application as of 26 May 2025, signed agreement with Notified Body by 26 Sept 2025, IVDR certification by 31 Dec 2027.

· Class C: Notified Body application by 26 May 2026, signed agreement with Notified Body by 26 Sept 2026, IVDR certification by 31 Dec 2028.

· Class B / A sterile: Notified Body application by 26 May 2027, signed agreement with Notified Body by 26 Sept 2027, IVDR certification by 31 Dec 2029.

On the reform proposal. The EU Commission's December 2025 proposal aimed at simplifying the MDR and IVDR regulatory framework is real and meaningful — but a few caveats matter. It does not affect IVD classification, it does not amend or extend the IVDR transitional periods, and it is not law yet — the proposal will undergo review, amendment, and publication. The final adopted text in the Official Journal of the European Union is expected in 2027, after which the implementation phase would begin; hence IVD manufacturers must keep working according to the current obligations in the meantime.

Where the challenges stand. IVD manufacturers who focus only on the IVDR transition deadline for their device class may assume they still have ample time. In practice, the volume of devices requiring transition, combined with limited Notified Body capacity, makes the timeline much tighter than it appears—even when the final deadline seems distant. Technical documentation typically takes 6–12 months to prepare before submission, and Notified Body review currently averages 12–18 months. If clinical performance studies are required, manufacturers should allow for an additional 12–24 months.

Common IVDR transition pitfalls — and how to avoid them

The IVDR transition is complex, but many of the common pitfalls can be avoided to ensure a smooth and timely transition.

· Incomplete submission. Incomplete or poorly structured technical files remain the most common cause of review delays. How to avoid: perform a gap assessment of your technical documentation before submission or conduct a mock review to IVDR requirements.

· Device misclassification. Misclassification of devices leads to delays and restart of the process – one of the most frequently flagged issues, alongside incomplete submissions. How to avoid: double-check and confirm your IVDR classification rationale. Many devices are now subject to far stricter requirements than under the IVDD.

· Inadequate clinical evidence. Clinical evidence generated under the old IVD Directive often no longer meets IVDR requirements. How to avoid: ensure the performance evaluation is a lifecycle-long process anchored in three pillars (scientific validity, analytical performance and clinical performance). It must be built from a formal plan, scaled to risk class, tightly linked to risk management and post-market surveillance, and continuously updated with new evidence.

· Late engagement. Late engagement with Notified Bodies significantly increases the risk of missed deadlines, delays, or losing legal market access in the EU. IVD manufacturers who wait risk ending up at the back of a long queue. How to avoid: ensure early Notified Body engagement and plan adequate time and resources for building an IVDR-compliant technical file.

Need support with your IVDR transition?

IVDR transition deadlines are approaching quickly, and navigating IVDR requirements is complex. At Aurevia, we guide manufacturers through every step — from device classification, clinical evidence, technical documentation, and Notified Body submission to quality management systems and post-market surveillance. Learn more