Medical Device: Clinical Evaluation Requirements

Inside this White Paper

Navigating the complexities of clinical evaluations is essential for medical device manufacturers aiming to secure and maintain market access in the European Union. This white paper from Regulatory Compliance Associates® offers practical guidance on aligning with EU MDR requirements, emphasizing the importance of thorough literature reviews, robust data analysis, and clear documentation. It addresses common pitfalls—such as inadequate inclusion criteria and insufficient linkage to essential requirements—and provides actionable strategies to enhance the quality and reproducibility of Clinical Evaluation Reports (CERs). Whether you’re preparing an initial submission or updating existing documentation, this resource is invaluable for ensuring your clinical evaluations meet regulatory expectations and withstand scrutiny from notified bodies.