Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

The PEP – Content (Annex XIII.1.1.) • Outline of different development phases including the sequence and means of determination of the scientific validity, the analytical and clinical performance, including an indication of milestones and description of potential acceptance criteria • Post-market performance follow-up (PMPF) plan • Performance Evaluation is a continuous process!

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Make the PEP work for you!

• The PEP is where: • You describe and justify your approach for the three elements of Clinical Evidence • E.g. for Clinical Performance: literature only? Why no Performance Study? • You justify what is not applicable to your device • You justify deviations from the ideal world • You define the basis for the assessment of the benefit-risk ratio • It is equally important for “legacy products” to explain how existing data have been used • For new products: to be integrated in design control.

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