Under the EU Medical Device Regulation (EU MDR), clinical evaluation plan & report writing is a fundamental regulatory activity required for all medical devices, regardless of risk class. Regulatory authorities and Notified Bodies now expect manufacturers to demonstrate, with structured clinical evidence, that a device is safe, performs as intended, and delivers meaningful clinical benefit throughout its lifecycle. Poorly structured clinical documentation is one of the most common causes of non-conformities, delayed CE marking, and extended review cycles. This guide outlines how manufacturers can prepare compliant Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) that align with EU MDR expectations and support long-term regulatory compliance.