IVD & Lab Instruments

EU IVDR Guide Shifts Importer Checks From Formality to Duty

EU IVDR Guide update: importer checks now shift from formality to duty. Learn how stricter verification, records, and supplier review will impact IVD shipments, contracts, and EU market access.

How to Evaluate Throughput and Test Menu in Automated In Vitro Diagnostic Equipment

Automated in vitro diagnostic equipment evaluation starts with real lab workload. Learn how to assess throughput, test menu, STAT handling, and hidden bottlenecks for smarter procurement.

FDA更新IVD进口商QMS合规要求

FDA updates IVD importer QMS compliance requirements: from Oct 1, 2026, validated QMS declarations and technical files must be ready before first import. Learn the key trade, contract, and customs impacts.

EU Tightens IVD Importer QMS Checks From Oct. 1, 2026

EU Tightens IVD Importer QMS Checks From Oct. 1, 2026. Learn how new IVDR importer QMS verification rules may affect batch records, CE files, distributors, and market access.

FDA Tightens IVD Importer Duties From Sept. 2026

FDA Tightens IVD Importer Duties From Sept. 2026: learn how new QSR 21 CFR Part 820 declarations, U.S. Agent filing, and remote audits may impact IVD exports, customs timing, and distributor compliance.

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.