IVD & Lab Instruments

EU IVD Transition Deadline Moved to March 2027

EU IVD Transition Deadline moved to March 2027: learn how the new IVDR timeline, clinical evidence template, and UDI database rules affect CE certification planning.

FDA Mandates Electronic UDI Filing for IVD Exports

FDA Mandates Electronic UDI Filing for IVD Exports: learn how the new FURLS rule impacts registration, customs clearance, labeling, and distributor inventory for U.S.-bound IVD shipments.

FDA Tightens Remote Monitoring Rules for IVDs

FDA tightens remote monitoring rules for IVDs: learn how the 2026 update impacts U.S. registration, software validation, firmware setup, and compliance readiness for exporters.

EU IVD Rule Adds Real-Time Remote Monitoring

EU IVD rule adds real-time remote monitoring for medium- and high-risk devices. Learn how Regulation (EU) 2026/1327 affects CE compliance, cybersecurity, cloud data governance, and EU market access.

FDA Opens Full Remote Review for IVD Submissions

FDA opens full remote review for IVD submissions, letting overseas manufacturers file 510(k), De Novo, and PMA documents electronically. Learn how this update may cut compliance costs and reshape U.S. market entry planning.

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.