Press release
Introduction to the Clinical Pathway Review (CPR)
Aug 18, 2026Before the formal technical documentation review begins, DEKRA offers a Clinical Pathway Review (CPR) to help you confirm critical aspects of your clinical evaluation at an early stage.
Without waiting for the technical documentation review to start, CPR focuses on key review considerations, such as literature search plan, clinical data sufficiency, PMCF/PMPF activities, and equivalence claims.
By identifying issues and gaps at an early stage and clarifying a clinical evaluation strategy aligned with regulatory requirements, you can reduce rework and help the technical documentation review proceed more smoothly.
Early planning, timely submission of clinical evaluation documentation, and proactive engagement with the Notified Body are key to achieving a smooth certification process. We invite you to use our CPR as the first step towards greater certainty in your certification journey.
For more information, please contact DEKRA.