Tagname : diagnostic reagents
![FDA Sets eLabel Rule for IVD Imports]( "FDA Sets eLabel Rule for IVD Imports")
FDA Sets eLabel Rule for IVD ImportsFDA Sets eLabel Rule for IVD Imports: learn how the new FDA eLabel Portal requirement from Oct 1, 2026 will impact IVD importers, exporters, labeling workflows, and customs compliance.![FDA Tightens IVD Import Filing for CE-IVDR Products]( "FDA Tightens IVD Import Filing for CE-IVDR Products")
FDA Tightens IVD Import Filing for CE-IVDR ProductsFDA 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, Adjusts IVD Window")
EU Extends MDR Deadline to Dec 2027, Adjusts IVD WindowEU 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.![EU Tightens e-UDI Rules for Imported IVD Reagents]( "EU Tightens e-UDI Rules for Imported IVD Reagents")
EU Tightens e-UDI Rules for Imported IVD ReagentsEU 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.
