Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

The PEP – Content (Annex XIII.1.1.)

• Intended purpose • Characteristics: • specifications for analytical and clinical performance characteristics • Characteristic of the intended purpose • Analyte or marker • Intended Use • Metrological traceability (quantitative assays): certified reference materials or reference measurement procedures • Specified target groups with clear indications, limitations and contra indications

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The PEP – Content (Annex XIII.1.1.)

• General safety and performance requirements (section 1-9 of Annex I) to be addressed in the Performance Evaluation • Methods to be used, including statistical tools, for the examination of performance • Description of the state of the art (How to do that?) • Specifications of parameters to be used to determine acceptability of benefit/risk ratio • For software: reference databases and other sources of data

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