Episode Details

This episode demystifies the essential processes of Clinical Evaluation and Clinical Investigation under the EU's Medical Device Regulation (MDR). We break down the entire lifecycle, from creating a Clinical Evaluation Plan (CEP) and gathering sufficient clinical data to compiling the Clinical Evaluation Report (CER) and executing Post-Market Clinical Follow-up (PMCF) to ensure long-term safety and performance. • What is a Clinical Evaluation, and why is it a continuous process? • When can you use existing literature versus needing a full clinical investigation? • What are the essential components of a Clinical Evaluation Plan (CEP)? • How has the EU MDR changed the requirements for demonstrating device equivalence? • What is the role of ISO 14155 in conducting clinical investigations? • How does the Clinical Evaluation Report (CER) prove a device's benefit-risk profile? • What is Post-Market Clinical Follow-up (PMCF), and how does it connect to vigilance? • How do you navigate the data requirements for legacy and high-risk devices? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.