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Deep dives on infectious disease diagnostics, molecular testing advances, AI in clinical science, regulatory updates, and global health — from our editorial team and invited contributors.

IVDR Implementation in 2026: What UK Diagnostic Manufacturers Must Do Now
Regulatory
Mar 2026 · 3 min read

IVDR Implementation in 2026: What UK Diagnostic Manufacturers Must Do Now

The EU In Vitro Diagnostic Regulation (IVDR) is now fully in force, and UK manufacturers exporting into Europe face a dual compliance landscape — UKCA marking domestically and CE-IVD for European markets. Here is what your regulatory team needs to action before year-end 2026. <br/><br/> We break down the technical file requirements, the notified body bottleneck, and the practical steps to maintaining market access on both sides of the Channel — with expert input from speakers confirmed for FutureDX 2026.

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