{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F6df09854-eeea-4051-a0cc-6c66ea61eb18","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations","description":"Agreement was reached on the eagerly awaited new EU Medical Device Regulations (MDR) and In-Vitro Diagnostics Regulations (IVDR) earlier this year.\n\nThis represents the single largest regulatory change in the EU in decades and it will affect ALL device manufactures selling in Europe.\n\nThe new MDR and IVDR are expected to be formally published any month now, and there will be a three-year transition period to be compliant.\n\nToday we\u2019re talking to Richard Young, the managing director of Acclaim Biomedical Consulting. He\u2019s speaking to us today about some of these changes in the EU. With over 20 year in the medical and in-vitro device regulation industry, Richard has good insight on what these changes are, how they came about, and how the new MDR and IVDR will affect medtech companies.\n\nSome of the topics you\u2019ll hear about today include:\n\n\u25cf\tAn overview of what\u2019s happening in Europe as far as MDR and IVDR.\n\u25cf\tHow these changes are impacting the burden of clinical evidence.\n\u25cf\tHow the periodic reporting regulations are changing.\n\u25cf\tRichard\u2019s thoughts on whether the EU regulatory processes will become more like the FDA processes.\n\u25cf\tWhether there will be changes on how medical and in-vitro devices are classified.\n\u25cf\tHow software and technology is playing into the decisions made to change some of the regulations.\n\u25cf\tEconomic influences and impacts that have affected some of the changes.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/ee8fa8e9-bde4-4f06-9ac0-8e47da88a72e/ee846f79-d622-4c64-8654-7646bd782635.jpg"}