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Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)


MDCG 2022-2 releases Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)


This document outlines the general principles of clinical evidence and provides guidance on the continuous process of performance evaluation for in vitro diagnostic medical devices.


Key Updates


  • This guidance describes the approach by which collection, generation and documentation of supporting data for an IVD may be conducted prior to the placing on the market or putting into service.
  • As the performance evaluation will be updated this document also addresses principles related to post-market surveillance, such as post-market performance follow-up.
  • Prior to placing an IVD on the market or putting it into service, the manufacturer must demonstrate compliance with all applicable requirements of the IVDR.
  • The manufacturer must demonstrate that the IVD achieves its intended purpose in accordance with the claimed performance over the lifetime of the device.
  • Manufacturer must specify and justify the level of clinical evidence in view of the characteristics of the device and its intended purpose.

IVD Performance Evaluation Process


IVD Scientific Validation Steps

The document highlights the following topics:

  • General principles of Clinical Evidence
  • Performance Evaluation
  • Performance evaluation process
  • The role of risk management in performance evaluation
  • Performance Evaluation Plan
  • Scientific Validity
  • Analytical Performance
  • Clinical Performance
  • Clinical performance studies
  • Performance Evaluation Report
  • Continuous update of the performance evaluation
  • Post-Market Surveillance (PMS) and Post-Market Performance Follow up (PMPF)



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MDCG Document