Module 19 2021

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

www.qarad.com

Slide 30 of 33