Unlocking Market Access: A Guide to Clinical Evaluation & Investigations
Medical Device Global Market Access · Pure Global
June 29, 20253m 41s
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Show Notes
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 [email protected] for tailored support.