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Pure Global's Ultimate Guide to Structuring Your EU IVDR 2017/746 Technical File for Market Success
This episode of MedTech Global Insights offers a deep dive into one of the most challenging aspects of European market access: structuring the technical file for the EU In Vitro Diagnostic Regulation (IVDR 2017/746). We break down the key requirements of Annex II, providing a clear roadmap for manufacturers to follow.
We move beyond theory to discuss the practical application of each section, from defining your device and its manufacturing processes to demonstrating compliance with the General Safety and Performance Requirements (GSPRs). We place special emphasis on the Performance Evaluation Report (PER), detailing the three pillars of evidence required by notified bodies: scientific validity, analytical, and clinical performance.
**Case Study:** A U.S.-based diagnostics innovator developed a groundbreaking liquid biopsy test for early cancer detection, a Class C device. They underestimated the IVDR’s demand for a standalone Performance Evaluation Report with robust clinical performance data. Their submission was rejected because they relied too heavily on existing literature instead of conducting a dedicated study on the European population. This resulted in a costly one-year delay, allowing a competitor to capture the market first.
**Key Takeaways:**
1. Why is the IVDR Technical File considered a "living document" and not just a one-time submission?
2. How can you create a GSPR checklist that satisfies a notified body auditor?
3. What are the three essential pillars of the Performance Evaluation Report (PER) that can make or break your submission?
4. What is the single biggest mistake companies make when documenting their design and manufacturing information?
5. For a high-risk IVD, how do you generate sufficient clinical performance data to prove your claims?
6. How does your ISO 14971 risk management file directly influence your benefit-risk analysis?
7. How can AI-driven tools prevent critical errors and accelerate the compilation of your technical documentation?
For more information or to discuss your regulatory strategy, contact us at [email protected] or visit https://pureglobal.com/.
View all episodes
By Ran ChenThis episode of MedTech Global Insights offers a deep dive into one of the most challenging aspects of European market access: structuring the technical file for the EU In Vitro Diagnostic Regulation (IVDR 2017/746). We break down the key requirements of Annex II, providing a clear roadmap for manufacturers to follow.
We move beyond theory to discuss the practical application of each section, from defining your device and its manufacturing processes to demonstrating compliance with the General Safety and Performance Requirements (GSPRs). We place special emphasis on the Performance Evaluation Report (PER), detailing the three pillars of evidence required by notified bodies: scientific validity, analytical, and clinical performance.
**Case Study:** A U.S.-based diagnostics innovator developed a groundbreaking liquid biopsy test for early cancer detection, a Class C device. They underestimated the IVDR’s demand for a standalone Performance Evaluation Report with robust clinical performance data. Their submission was rejected because they relied too heavily on existing literature instead of conducting a dedicated study on the European population. This resulted in a costly one-year delay, allowing a competitor to capture the market first.
**Key Takeaways:**
1. Why is the IVDR Technical File considered a "living document" and not just a one-time submission?
2. How can you create a GSPR checklist that satisfies a notified body auditor?
3. What are the three essential pillars of the Performance Evaluation Report (PER) that can make or break your submission?
4. What is the single biggest mistake companies make when documenting their design and manufacturing information?
5. For a high-risk IVD, how do you generate sufficient clinical performance data to prove your claims?
6. How does your ISO 14971 risk management file directly influence your benefit-risk analysis?
7. How can AI-driven tools prevent critical errors and accelerate the compilation of your technical documentation?
For more information or to discuss your regulatory strategy, contact us at [email protected] or visit https://pureglobal.com/.