Laboratory Developed Test (LDT) vs IVD Validation Workflow

Learn more about changes coming to Laboratory Developed Tests regulation from our infographic.






  Performance verification   Performance validation  
  No EU standard.
According National Accreditation Requirement Country specific, could be ISO15189






using CE-IVD reagents according to IFU


with non-CE reagents or deviating from IFU but meeting article 5.5 requirements


with non-CE reagents or deviating from IFU and not meeting article 5.5 requirements

  Performance verification
  Assay performance validation*
  Justify absence of CE marked reagents meeting performance requirements
  Performance validation according to ISO 15189*
        Performance validation according to ISO 15189*
  IVDR Annex I GSPR **
        Full ISO 15189* compliance
  Post-Market surveillance process
          IVDR Annex I GSPR **
  Appropriate quality management system for manufacturing (e.g. ISO 13485)
  No major changes versus IVDD workflow   Post-Market surveillance process  

Compliance with full IVDR



The clinical lab is regarded as an IVD manufacturer marketing a new IVD assay and must meet the same requirements as an IVD manufacturer (clinical evidence, contracting notified body…)


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*EN ISO 15189 standard or, where appropriate, national regulations including national accreditation rules

Chapter I: Risk management system: identify, evaluate and eliminate/reduce risks
Chapter II: Performance, design and manufacture
Chapter III: Information provided with the device. Labelling & Instruction For Use

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