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…)

 
 

Download this infographic as pdf

*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