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Episode 103  |  32:06 min

EU MDR: Not All Doom and Gloom

Episode 103  |  32:06 min  |  11.07.2019

EU MDR: Not All Doom and Gloom

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This is a podcast episode titled, EU MDR: Not All Doom and Gloom. The summary for this episode is: Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MDR)? In this episode, Rebecca Sheridan shares some positive insights and updates regarding EU MDR and its In Vitro Diagnostic Regulation (IVDR). Rebecca is a former regulator herself, and now serves as Senior Director for Quality Assurance, Regulatory Affairs, and Clinical Affairs for the Advanced Wound Franchise of ConvaTec Limited. Some of the highlights of the show include: ● EU MDR transition timeframe is very optimistic due to the complexity of today’s medical devices. ● The infrastructure needed to navigate through the regulations is still in progress. So, minimal guidance is a major challenge for the medical device industry. ● The medical device industry is at a crisis point where collaboration must occur to be able to support patients, public health, and healthcare institutions. ● An extension would pose additional challenges. The legal process takes time, decreases available resources, and delays implementation of changes. ● The capacity of notified bodies is expected to increase by the end of this year. Many devices need to go through process that were previously unregulated. ● Don’t panic, stay calm. Engage early on with notified body and provide technical documentation and clinical data regarding design controls. ● During the post-market phase, EU MDR/IVDR will impact companies’ quality management system (QMS) and infrastructure due to required reporting. Download our free EU MDR gap analysis tool here → https://www.greenlight.guru/mdr-gap-analysis-tool
Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MDR)? In this episode, Rebecca Sheridan shares some positive insights and updates regarding EU MDR and its In Vitro Diagnostic Regulation (IVDR). Rebecca is a former regulator herself, and now serves as Senior Director for Quality Assurance, Regulatory Affairs, and Clinical Affairs for the Advanced Wound Franchise of ConvaTec Limited. Some of the highlights of the show include: ● EU MDR transition timeframe is very optimistic due to the complexity of today’s medical devices. ● The infrastructure needed to navigate through the regulations is still in progress. So, minimal guidance is a major challenge for the medical device industry. ● The medical device industry is at a crisis point where collaboration must occur to be able to support patients, public health, and healthcare institutions. ● An extension would pose additional challenges. The legal process takes time, decreases available resources, and delays implementation of changes. ● The capacity of notified bodies is expected to increase by the end of this year. Many devices need to go through process that were previously unregulated. ● Don’t panic, stay calm. Engage early on with notified body and provide technical documentation and clinical data regarding design controls. ● During the post-market phase, EU MDR/IVDR will impact companies’ quality management system (QMS) and infrastructure due to required reporting. Download our free EU MDR gap analysis tool here → https://www.greenlight.guru/mdr-gap-analysis-tool

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