{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F3a21538c-46d8-4d1c-b41e-f393a47c4662","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near","description":"The end of 2020 is near, which will close out a year that\u2019s been fraught with challenges and difficulties. However, 2021 will bring its own set of new challenges for those implementing the European Union Medical Device Regulation/In-Vitro Diagnostics Regulation (EU MDR/IVDR). What do device companies still need to do to be prepared for the transition?\nIn this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-Owner of \u200eQUNIQUE Group, a quality and regulatory consultancy.\nBassil offers expert advice on how device companies need to prepare for these regulatory deadlines and transition to meeting the requirements of EU MDR/IVDR sooner rather than later.\nSome of the highlights of the show include:\nCOVID-19 is an additional burden by impacting implementation, increasing requirements, and not being transparent about limited notified body capacity.\nEU MDR/IVDR Readiness: Under the new legislation, every device needs to receive re-certification by notified bodies to keep market access.\nEU MDR/IVDR Challenges:\nAdditional guidance needed during transition to apply these regulations.\nRegulations put expectations that are not ready, such as EUDAMED.\nIncreased requirements on clinical evidence via higher clinical and performance evaluation requirements.\nContinuous reporting increases expectations on resources for new and existing medical devices.\nEU MDR/IVDR Timeline: Number of notified bodies isn\u2019t the most important part. How much capacity do those notified bodies have to address market needs?\nTips for Medical Device and In-vitro Diagnostic Companies:\nRead the regulation(s).\nUnderstand implication(s) of regulation(s) on system(s).\nIdentify/re-evaluate notified bodies that can address needs.\nManage timeline/deadline for submission, implementation, certification.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/19ca5479-fa7a-4526-b69e-b7880084c888/d18249c2-41a1-460c-b0d3-0e4636cb86fe.png"}