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Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?
- Author: Vários
- Narrator: Vários
- Publisher: Podcast
- Duration: 0:38:03
- More information
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Synopsis
Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible.In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP of Quality Systems at MDC Associates, shine light on EU IVDR transition concerns and the challenges the medical device industry faces, like the notified body shortage.Some highlights of this episode include:Why are some notified bodies not interested? There’s a ton of work, audits, and corrective actions. They don’t view it as necessary to move forward and pursue.First, notified bodies plan a wait-and-see approach to find out how the EU MDR goes on May 27. The notified bodies are overwhelmed and resources are limited.The EU MDR has more constituents involved and is a bit more straightforward to implement than the IVDR. The IVDR has less constituents but more things th