Under EU MDR, the Clinical Evaluation Plan is far more than a procedural document. It is the foundation of your clinical evidence strategy and a key part of demonstrating that your device is safe, performs as intended, and maintains a positive benefit–risk profile throughout its lifecycle. For many manufacturers, especially those working with legacy devices, existing data, or evolving Notified Body expectations, the CEP can quickly expose gaps in clinical reasoning, evidence justification, clai

What Are the Key Factors That Make a Clinical Evaluation MDR-Ready?