The transition to the EU In Vitro Diagnostic Regulation (IVDR) is now in its final and most critical phase. For manufacturers relying on transitional provisions for legacy IVD devices, the deadline of 26 May 2026 is rapidly approaching.
This is no longer a distant regulatory milestone — it is an active compliance requirement that will determine continued access to the EU market for many products.
At the same time, Notified Bodies continue to face significant capacity constraints, making timely preparation a key factor in avoiding delays and potential disruption.
Key requirements under the transitional provisions (where applicable)
Manufacturers must ensure that essential IVDR readiness activities are well underway, including:
- An IVDR-compliant Quality Management System (QMS)
- Submission of applications to a Notified Body for relevant devices
- A signed agreement with a Notified Body within applicable timelines
- Control of changes to device design and intended purpose
- Ongoing compliance with applicable IVDR requirements (including PMS, vigilance, and PRRC)
Why this matters
Missing critical steps within the transitional framework may result in loss of eligibility to continue placing devices on the EU market under legacy provisions, with potential impact on supply continuity and market access.
With Notified Body capacity already under pressure, early and structured preparation is more important than ever.
Need support with your IVDR transition?
Navigating IVDR requirements and timelines can be complex — especially when balancing regulatory expectations, documentation, and Notified Body readiness.
We help manufacturers structure and accelerate their IVDR compliance work to reduce risk and avoid unnecessary delays.
Learn more about how we can support you here.
