EU MDR Expert Panel Feedback (#5) | MedTech Voices

🗣️ We're excited to release the fifth installment of our MedTech Voices mini series about 𝐄𝐔 𝐌𝐃𝐑 𝐄𝐱𝐩𝐞𝐫𝐭 𝐏𝐚𝐧𝐞𝐥 𝐅𝐞𝐞𝐝𝐛𝐚𝐜𝐤. If you've been following along, this series is all about sharing perspectives on the feedback (CECP per EU MDR, Article 54) from clinical reviews completed over the last year.
𝘐𝘴 𝘵𝘩𝘦 𝘳𝘦𝘱𝘰𝘳𝘵 𝘥𝘪𝘴𝘤𝘶𝘴𝘴𝘦𝘥 𝘪𝘯 𝘵𝘩𝘪𝘴 𝘤𝘭𝘪𝘱 𝘴𝘦𝘯𝘥𝘪𝘯𝘨 𝘢 𝘣𝘢𝘥 𝘮𝘦𝘴𝘴𝘢𝘨𝘦 𝘵𝘰 𝘮𝘢𝘯𝘶𝘧𝘢𝘤𝘵𝘶𝘳𝘦𝘳𝘴? 🤔
👨‍🏫 Jaishankar Kutty, Ph.D., VP of Intelligence and Innovation, is joined once more by Medical Director 👩‍🏫 Sally Sennitt. This clip focuses on a transcatheter heart valve – likely a balloon-expandable valve – and the report wasn't positive (even troubling). Our experts go into meaningful detail as to why.
Questions covered 👇
1️⃣ What was your overall feeling about this one?
2️⃣ What were some of your takeaways on the panel's comments and what was submitted to them?
3️⃣ What does this mean for manufacturers?
We appreciate you listening!

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