Module 19 2021

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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