Clinical investigations are clinical studies in human subjects that assess the safety and/or performance of a medical device. Prior to starting a clinical investigation, it is important to assess the scope of the investigation and whether it is needed at all. A pre-CE clinical investigation is often the cornerstone of evidence that proves your medical device is ready to enter the market. Data from the clinical investigation becomes input for your clinical evaluation. Prior to starting the clinical investigation, a Clinical Evaluation Plan (CEP) must be developed. A CEP in MDR is designed to guide manufacturers in conducting robust and systematic clinical evaluations, leading to the generation of reliable evidence supporting the safety and performance of medical devices. It is a critical component of the regulatory process and helps ensure patient safety and public health.