Laboratory Developed Test (LDT) vs IVD Validation Workflow

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

IVDD — TODAY
 
 

IVD

  

LDT

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

 

IVDR — TOMORROW
 
 

IVD

  

LDT
using CE-IVD reagents according to IFU

  

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

  

LDT
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…)

  
 

*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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