Regulatory Open Forum

Dear Community,

I am seeking some help in identifying the difference between 'Scientific peer reviewed literature' and 'published experienced gained' in the context of IVDR clinical evidence.

To me, there is significant overlap on what can be used for either. Of course, published experienced gained can utilize PMPF studies, and customer published data etc but wouldn't device specific peer reviewed literature essentially also be published experienced gained?

Can someone point me in the direction of a documented detailed distinction between the two data sets?

Much appreciated.

Hi, I agree there is overlapping in both. Based on the type of the IVD we can utilize these for different aspects of clinical evaluation.

 For example -peer reviewed literature can be used in the determination of scientific validity, where analyte is associated to a well-known clinical condition/physiological state. 

Experienced gained by routine diagnostic testing can be used for clinical performance data 

peer reviewed literature

Literature searching can be used to identify published clinical performance data that is not in the possession of the manufacturer that may assist the manufacturer in establishing acceptable clinical performance of an IVD medical device. The data generated through literature searching should relate directly to the IVD medical device in question or earlier versions with justification as to why the data for the earlier versions are applicable (e.g. reports of clinical studies that have been performed by third parties).

Experience gained by routine diagnostic testing
These types of performance data are generated in actual use conditions that are outside the conduct of clinical performance studies. While much of the experience with routine diagnostic testing is found in literature, additional data may include:  manufacturer-generated post-market surveillance data (e.g. customer testing results)
 adverse events databases (held by either the manufacturer or Regulatory Authorities)
 data for the device in question generated from individual patients under emergency (e.g. test for H1N1 in 2009) prior to marketing of the IVD medical device
 details of clinically relevant field safety corrective actions (e.g. recalls, notifications, hazard alerts

There should be careful selection of the routine diagnostic test(s) which will be used as the comparative method to evaluate the performance of an IVD medical device. Where possible, a reference test method should be included in the performance study protocol and qualified with appropriate reference to the literature.

Dear Community,

I am seeking some help in identifying the difference between 'Scientific peer reviewed literature' and 'published experienced gained' in the context of IVDR clinical evidence.

To me, there is significant overlap on what can be used for either. Of course, published experienced gained can utilize PMPF studies, and customer published data etc but wouldn't device specific peer reviewed literature essentially also be published experienced gained?

Can someone point me in the direction of a documented detailed distinction between the two data sets?

Much appreciated.

Hello Anon,

Indeed as Raje indicated there is some overlap.  When we are putting together a Performance Evaluation file, we do try to clarify or define what each of these are in regard to the EU IVDR regulation.  However, it may not always be clear - I think most do not struggle with the peer reviewed literature, but struggle more with what is considered 'experience gained by routine testing.'  Initially I thought this was only post market data, but reading through some of the GHTF/IMDRF and MDCG guidance documents seems to indicate this might not just be post market data.  We also generally put post market data in its own section/category in the Performance Evaluation report.  I think experience gained by routine testing also includes testing such as for WHO panels or CAP Surveys.  This is definitely an evolving area and without a specific definition and/or example of what constitutes experience gained by routine testing, we strongly recommend clearly defining this within your own process.

Hi, I agree there is overlapping in both. Based on the type of the IVD we can utilize these for different aspects of clinical evaluation.

 For example -peer reviewed literature can be used in the determination of scientific validity, where analyte is associated to a well-known clinical condition/physiological state. 

Experienced gained by routine diagnostic testing can be used for clinical performance data 

peer reviewed literature

Literature searching can be used to identify published clinical performance data that is not in the possession of the manufacturer that may assist the manufacturer in establishing acceptable clinical performance of an IVD medical device. The data generated through literature searching should relate directly to the IVD medical device in question or earlier versions with justification as to why the data for the earlier versions are applicable (e.g. reports of clinical studies that have been performed by third parties).

Experience gained by routine diagnostic testing
These types of performance data are generated in actual use conditions that are outside the conduct of clinical performance studies. While much of the experience with routine diagnostic testing is found in literature, additional data may include:  manufacturer-generated post-market surveillance data (e.g. customer testing results)
 adverse events databases (held by either the manufacturer or Regulatory Authorities)
 data for the device in question generated from individual patients under emergency (e.g. test for H1N1 in 2009) prior to marketing of the IVD medical device
 details of clinically relevant field safety corrective actions (e.g. recalls, notifications, hazard alerts

There should be careful selection of the routine diagnostic test(s) which will be used as the comparative method to evaluate the performance of an IVD medical device. Where possible, a reference test method should be included in the performance study protocol and qualified with appropriate reference to the literature.

Dear Community,

I am seeking some help in identifying the difference between 'Scientific peer reviewed literature' and 'published experienced gained' in the context of IVDR clinical evidence.

To me, there is significant overlap on what can be used for either. Of course, published experienced gained can utilize PMPF studies, and customer published data etc but wouldn't device specific peer reviewed literature essentially also be published experienced gained?

Can someone point me in the direction of a documented detailed distinction between the two data sets?

Much appreciated.