Stuck in a Holding Pattern: The IVDR Revision and Planning for Two Markets at Once

The 2026 IVDR transition deadlines are here, and a lot of IVD companies are sitting still. After the European Commission proposed a revision to the regulation in December 2025, many manufacturers are waiting to see what survives before they file. By late May, notified bodies reported that submissions had slowed so much that some have cut staff and a few may close. The old IVDD deadlines keep running out, the dates for higher-risk classes have already passed, and the Commission's message has been consistent: no more extensions. Dan Simpson, Director of Regulatory Affairs at DCN Dx, and Sarah Barchard, Senior Clinical Trials Manager at DCN Dx, talk through what the waiting costs a company that has to sell in both the EU and the US, and why it pays to plan for both markets at the same time instead of one after the other. Dan takes the regulatory side: where the two systems differ, and how those differences shape design and development long before anyone files. Sarah takes the clinical side: where EU and US requirements pull in different directions during analytical and clinical work, and what it takes to run studies that hold up in both places. This conversation leads into their RAPS sponsored webcast, The IVDR Transition in 2026: Parallel Regulatory Planning for EU and US Market Entry, on June 17 at 12pm ET. It's free, and you can register through RAPS. Dan and Sarah will walk through the case studies behind what they discuss here. Register: ⁠https://www.raps.org/learn-develop/events/sponsored-webcast-the-ivdr-transition-in-2026-parallel-regulatory-planning-for-eu-and-us-market-entry.html⁠ Talk through your own program: ⁠dcndx.com/contact