New Guidance Document Details Clinical Evidence Requirements under IVDR. Now What?

The long-awaited Medical Device Coordination Group (MDCG) Guidance on Clinical Evidence is now available.  The 31-page document, MDC 2022-2, outlines how clinical evidence is to be demonstrated pursuant to the requirements of the IVDR. 

What does this mean for study sponsors and manufacturers? In short, the need for continuous oversight of clinical data and performance evaluation throughout the IVD’s entire lifecycle from pre-market release to post-market surveillance and follow-up. 

The guidance, which also includes more than 5 pages of definitions, details the specific principles and procedures to follow over the entire lifetime of a product, with dedicated sections across the following areas: 

  • General principles of Clinical Evidence
  • Performance evaluation process
  • The role of risk management in performance evaluation 
  • Performance Evaluation Plan (PEP) 
  • Scientific Validity, Analytical Performance and Clinical Performance 
  • Performance Evaluation Report (PER) 
  • Continuous update of the performance evaluation 

The last point on continuous performance evaluation reflects the overarching approach manufacturers must adopt, as stated in the excerpt below: 

“Scientific developments and improvements in state-of-the-art should be reviewed and assessed by the manufacturer on a regular basis as part of their continuous and pro-active postmarket surveillance activities. Therefore, manufacturers must instate a procedure for planned monitoring of scientific developments and changes in medical practice relevant to the IVD(s). Any relevant new information, developments and progress in the scientific field should trigger reassessments of the existing clinical evidence thus ensuring safety and performance through a continuous performance evaluation process.” 

This guidance document also includes an appendix on the methodological principle for generating clinical evidence as well as the required frequency for updating reports. All of which reinforces the critical need for a systematic approach to short and long-term study planning – and the benefit of having Beaufort’s highly-skilled IVDR team by your side. 

Download the Full MDCG 2022-2 Guidance Document 

Date posted: February 1, 2022

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