A top podcast for healthcare leaders, with over one million downloads, Radio Advisory is your weekly download on how to untangle the industry's most pressing challenges to help leaders like you make the best business decisions for your organization. From unpacking major trends in care delivery—like site-of-care shifts and the rise of high-cost drugs—to demystifying stakeholder dynamics, to shining a spotlight on priorities that may get overlooked, we're here to help. Our hosts and seasoned r ...
…
continue reading
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Will it be really difficult for IVD manufacturers? [IVDR 2017/746]
Manage episode 288737970 series 2591977
Content provided by Monir El Azzouzi. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Monir El Azzouzi or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
We talked a lot about the EU MDR and the difficulty for some manufacturers to transition to this new legislation. But today we will explain why IVDR manufacturers will struggle more. I will explain to you the change in terms of product classification within the IVDR 2017/746. Because of this, a lot of manufacturers that didn’t need a Notified Body before will need one now. And as you may know, as of today, the number of Notified Bodies is not really high. So I hope this episode will help you understand the situation for the IVD business as there is a risk for manufacturers but also for patients.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links
- Notified Bodies IVR Codes: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R2185&from=EL
- Medtech – IVD symbols: https://www.medtecheurope.org/wp-content/uploads/2020/10/medtech-europe-new-ivd-symbols-for-compliance-with-the-ivdr-october-2020.pdf
- MDCG 2020-16 – IVD classification: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_guidance_classification_ivd-md_en.pdf
- Covid-19 Q&A: https://ec.europa.eu/health/sites/health/files/md_sector/docs/covid-19_ivd-qa_en.pdf
- Podcast episode 99 – IVDR Self-testing: https://podcast.easymedicaldevice.com/99/
- Podcast episode 42 – New Rules IVDR: https://podcast.easymedicaldevice.com/42/
The post Will it be really difficult for IVD manufacturers? [IVDR 2017/746] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
311 episodes
Share
Manage episode 288737970 series 2591977
Content provided by Monir El Azzouzi. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Monir El Azzouzi or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
We talked a lot about the EU MDR and the difficulty for some manufacturers to transition to this new legislation. But today we will explain why IVDR manufacturers will struggle more. I will explain to you the change in terms of product classification within the IVDR 2017/746. Because of this, a lot of manufacturers that didn’t need a Notified Body before will need one now. And as you may know, as of today, the number of Notified Bodies is not really high. So I hope this episode will help you understand the situation for the IVD business as there is a risk for manufacturers but also for patients.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links
- Notified Bodies IVR Codes: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R2185&from=EL
- Medtech – IVD symbols: https://www.medtecheurope.org/wp-content/uploads/2020/10/medtech-europe-new-ivd-symbols-for-compliance-with-the-ivdr-october-2020.pdf
- MDCG 2020-16 – IVD classification: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_guidance_classification_ivd-md_en.pdf
- Covid-19 Q&A: https://ec.europa.eu/health/sites/health/files/md_sector/docs/covid-19_ivd-qa_en.pdf
- Podcast episode 99 – IVDR Self-testing: https://podcast.easymedicaldevice.com/99/
- Podcast episode 42 – New Rules IVDR: https://podcast.easymedicaldevice.com/42/
The post Will it be really difficult for IVD manufacturers? [IVDR 2017/746] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
311 episodes
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Similar to Medical Device made Easy Podcast
A top podcast for healthcare leaders, with over one million downloads, Radio Advisory is your weekly download on how to untangle the industry's most pressing challenges to help leaders like you make the best business decisions for your organization. From unpacking major trends in care delivery—like site-of-care shifts and the rise of high-cost drugs—to demystifying stakeholder dynamics, to shining a spotlight on priorities that may get overlooked, we're here to help. Our hosts and seasoned r ...
…
continue reading
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The best sales leaders in the world are revealing their points of view, playbooks, and tried and true tactics...only on Reveal: The Revenue Intelligence Podcast. Join us each month as host Dana Feldman digs deep into the world of the sales leaders she admires and aspires to be from some of the largest and most prominent organizations. Whether you're a CRO or aspiring to be one, these conversations will help you lead teams well, surpass revenue goals, and stay ahead of industry trends. Dana F ...
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continue reading
A daily show for everyone who works a regular job and wants to start an income-earning project on the side. In each episode, listeners will hear a different story of someone who's started a side hustle—along with what went well, how that person overcame challenges, and what happened as a result. The show is written and hosted by Chris Guillebeau, the New York Times bestselling author of The $100 Startup, The Happiness of Pursuit, and other books.
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