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IVD Regulations in 2026: EU IVDR, FDA Requirements, Performance Evaluation and Global Compliance

IVD regulations now decide market access in both the EU and US. Learn how notified bodies test classification, performance evaluation and transition status, where IVDR and FDA requirements differ, and which compliance gaps auditors’ flag most often.
  • Blog, Medical Devices
Modern diagnostic laboratory showing IVD testing equipment, regulatory documentation, and EU-US market access under IVDR and FDA requirements.

IVD Registration in 2026: IVDR Classification, CE Marking and Global Market Access

IVD registration under the EU IVDR demands more than paperwork. Discover how risk classification, performance evaluation, CE marking, and EUDAMED requirements shape market access, and learn the essential steps to avoid costly regulatory delays and certification setbacks.
  • Blog, Medical Devices
Laboratory testing equipment, blood samples, and digital regulatory documents illustrating IVD CE marking, performance evaluation, and European market access.