As we move into the second quarter of 2026, the regulatory landscape for In Vitro Diagnostics (IVD) in the European Union is reaching a critical inflection point. While the transition from the IVDD to the In Vitro Diagnostic Regulation 2017/746 (IVDR) has been extended for legacy devices via Regulation (EU) 2024/1860, those extensions are not unconditional.
For manufacturers of legacy devices which fall under IVDR risk class C, a significant milestone is now just weeks away.
Class C devices include a wide range of tests, such as many infectious disease tests, cancer screening tests, and companion diagnostics.
To benefit from the extended transition period, which allows such legacy devices to remain on the market until December 31, 2028, manufacturers must meet specific regulatory milestones:
- By May 26, 2026, a formal application for conformity assessment must be filed with an IVDR Notified Body.
- By September 26, 2026, a formal written agreement must be signed with that Notified Body.
Bottom line
Failure to meet the May 26, 2026, application deadline means these legacy devices lose their “transition status”. Without a valid IVDR Notified Body application or contract, these products are no longer in compliance with the IVDR transition requirements.
How can MDSS support your IVDR application?
Our team specializes in EU IVDR assessment, and we can assist you with Notified Body application support and communication.
After signing the Notified Body agreement, the journey is not over. The Technical Documentation has to be updated to meet the IVDR requirements. It is understood that the IVDR conformity assessment process is lengthy and complex, and longer assessment times are anticipated — but with MDSS on your side, the process becomes faster, smoother, and more efficient.
We are also able to assist you with:
- Technical Documentation preparation and gap analysis
- Performance Evaluation Plans and Performance Evaluation Reports (PEP/PER)
- Quality Management System (QMS) implementation
Act before the deadline acts for you
With 26 May 2026 only weeks away, early engagement can make the difference between continued market access and forced product withdrawal.
📅 Schedule a brief introductory call now! Don’t wait until the option for additional 2.5 years of transition has passed.
Reach out today to ensure your legacy devices stay on the EU market through 2028—and beyond.
