IVD & Lab Instruments

EU Sets New IVD Filing Rule From August 1

EU Sets New IVD Filing Rule From August 1: learn how UDI-DI, EUDAMED, and CE-IVDR filing changes may affect customs clearance, launch timing, and EU market access.

FDA Tightens IVD Import Filing for CE-IVDR Products

FDA Tightens IVD Import Filing for CE-IVDR Products: learn how the new FDA rule affects customs clearance, compliance timing, and U.S. market access for IVD manufacturers and buyers.

EU Extends MDR Deadline to Dec 2027, Adjusts IVD Window

EU extends MDR deadline to Dec 2027 and adjusts the IVD transition window to Q1 2028. See what this means for CE certification, export planning, compliance timing, and inventory strategy in Europe.

Automated Molecular Testing Systems: Key Validation Points Before Adoption

Automated molecular testing systems: discover the key validation points before adoption, from workflow fit and IT integration to reagent supply, uptime, and long-term cost.

FDA Speeds EUA Review for COVID-Flu Combo IVDs

FDA Speeds EUA Review for COVID-Flu Combo IVDs: learn how the new 48-hour pathway may reshape U.S. market entry, clinical filing, inventory planning, and distributor timing.

EU Tightens e-UDI Rules for Imported IVD Reagents

EU Tightens e-UDI Rules for Imported IVD Reagents: learn how the 2026 IVDR update impacts packaging, EUDAMED uploads, and export compliance planning for EU market access.

FDA Sets New Multilingual E-Label Rule for IVD Imports

FDA multilingual e-label rule reshapes IVD imports from Sept. 1, 2026. Learn how eSTAR verification, bilingual labeling, and compliance planning can prevent customs delays.

EU IVD Guidance Tightens Batch Traceability

EU IVD Guidance Tightens Batch Traceability: learn how IVDR batch-level EUDAMED reporting and remote audits may affect EU market access, customs clearance, and exporter readiness.

How to Build a Laboratory Workflow Dashboard That Improves Lab Turnaround Time

Laboratory workflow dashboard strategies that help labs reduce turnaround time, spot bottlenecks faster, improve staffing visibility, and turn real-time data into better daily decisions.

FDA Tightens IVD Import Rules From August 2026

FDA Tightens IVD Import Rules From August 2026: learn how new FDA requirements for UDI-DI+PI, URLS registration, and real-time batch traceability will impact IVD imports, labeling, and distribution.