Regulatory reporting of IVD Performance
The In Vitro Diagnostic Medical Device Regulation (IVDR), set to be in full force by 2022, outlines a variety of reports that must be written to demonstrate the scientific validity, analytical performance, and clinical performance of the IVD.
The nature and extent of the IVD’s scientific validity is to be documented in the scientific validity report. Data for this evaluation should come from relevant information on the scientific validity of other devices that measure the same analyte or marker, a review of the scientific literature, consensus expert opinions, or results from proof of concept studies, and/ or results from clinical performance studies.
The nature and extent of the IVD’s analytical performance data is to be demonstrated and documented in the analytical performance report. The IVDR advises that the analytical performance should be demonstrated on the basis of analytical performance studies. However, for novel markers or other markers that do not have certified reference materials or reference measurement procedures available, comparison to other well-documented methods or reference standards should be made. In the absence of any of the above approaches, a clinical performance study designed to compare the performance of the novel IVD to the current clinical standard practice should be conducted and reported here.
A comprehensive demonstration of the clinical performance data is to be documented in the clinical performance report. This evaluation should be based on clinical performance studies unless due justification can be provided for relying on other sources such as scientific peer-reviewed literature and published experience gained by routine diagnostic testing. Any new conclusions derived from Postmarket Performance Follow-up reports should also be included.
The reports of this 3-fold performance evaluation should then be compiled into a new document called the Performance Evaluation Report and is to be updated throughout the life cycle of the IVD. This will aid regulators and manufacturers alike to assess the combined evidence in order for the IVD to both obtain and maintain the CE mark.
The Performance Evaluation Report thus forms a key part of the overall technical documentation and requires significant planning and writing resources to be satisfactorily compliant with the stipulations of the new IVDR.
In Vitro Diagnostic Medical Device Regulation: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance.) Available online (Accessed 17 August 2020)
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