NOTE: This episode was recorded prior to the EU Commission Proposal and now EU Parliament approval; pending EU Council (member states approval) and publication in the official journal (OJEU) for the official postponement of EU MDR. Once official, the DoA would be amended by one year, so when referring to the DoA as 26 May 2020 this would now be 26 May 2021. This live episode of the Global Medical Device Podcast was recorded at the Greenlight Guru True Quality Roadshow in Houston, with host Jon Speer his special guest Evangeline Loh, vice president of regulatory affairs at Emergo Group. Together they discuss key challenges medical device professionals are facing with EU MDR, how to best manage those challenges, and its impact on the medical device ecosystem. Some of the highlights of the show include: - EU MDR: The medical device regulation was scheduled to start on May 26, 2020, but will likely be postponed due to disruptions caused by the COVID-19 pandemic. - Second Corrigendum: Self-certified Class I medical devices under the current MDD 93/42/EEC will be up-classified under MDR and will not need to be certified to the new regulation until May 25, 2024. - Ecosystem Challenge: Delays have the medical device enterprise scrambling to find systems to register and market their medical devices to be compliant. - Number of Notified Bodies: MDR has 11 designated notified bodies, which is a significant increase. EU Commission plans to designate several more soon. - Beat the Clock: The advantage to receiving MDR certification before May 2024 by engaging a notified body to review/issue it is to become a legacy device. - Brexit (UK withdraws from EU): How will it impact and be impacted by EU MDR? From a regulatory regime perspective, it represents more work and duplication. - Despite delays, deadlines are approaching and will impact everyone. It’s important to monitor and understand what’s happening around the world.