Watch the webinar: IVDR Class C Transition Period and Certification Readiness
The In Vitro Diagnostic Regulation (IVDR) transition period for many Class C legacy IVDs is moving rapidly toward critical regulatory milestones.
To maintain market access through Dec. 31, 2028, manufacturers must meet these mandatory Article 110 conditions and transition deadlines.
Critical Class C deadlines
- May 26, 2025 – Quality management system (QMS) compliant with Article 110*
- May 26, 2026 – Formal application lodged for IVDR conformity assessment (contact us).
- Sept. 26, 2026 – Signed written agreement with a Notified Body (NB)
*Regulatory note: Transition provisions apply only to eligible legacy devices and are subject to the conditions set out in Article 110 IVDR, as amended by Regulation (EU) 2024/1860.
Watch our on-demand webinar and learn more about IVDR Class C transition deadlines, milestones and how to prepare for certification before the window closes.
What you will learn
- The IVDR transition road map for Class C legacy devices.
- Strategies to benefit from the transition period.
- Process for application to QMD Services with UL Solutions.
- Documentation for best practices during transition.
Our IVDR certification services
In strategic collaboration with Notified Body QMD Services (2962), UL Solutions provides IVDR certification under Regulation (EU) 2017/746 (IVDR).
By initiating your inquiry directly with UL Solutions, you can secure your formal IVDR application for legacy devices ahead of the critical transition deadlines.
Contact us today to get started.
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