Module 19 2021

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!

www.qarad.com

Slide 31 of 33