IVDR

科學

EP256-歐盟醫材生存遊戲：誰在火車後苦追，誰在「原地合規」？

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<blockquote class="wp-embedded-content" data-secret="s0I2UCdSx7"><a href="https://podcast.biomeder.com/episodes/eu-mdr-survival-game-compliance-race/">EP256-歐盟醫材生存遊戲：誰在火車後苦追，誰在「原地合規」？</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://podcast.biomeder.com/episodes/eu-mdr-survival-game-compliance-race/embed/#?secret=s0I2UCdSx7" width="500" height="350" title="EP256-歐盟醫材生存遊戲：誰在火車後苦追，誰在「原地合規」？ &#8212; 生醫人生旅歷" data-secret="s0I2UCdSx7" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script> /*! This file is auto-generated */ !function(d,l){"use strict";l.querySelector&&d.addEventListener&&"undefined"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!/[^a-zA-Z0-9]/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret="'+t.secret+'"]'),o=l.querySelectorAll('blockquote[data-secret="'+t.secret+'"]'),c=new RegExp("^https?:$","i"),i=0;i<o.length;i++)o[i].style.display="none";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute("style"),"height"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):"link"===t.message&&(r=new URL(s.getAttribute("src")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener("message",d.wp.receiveEmbedMessage,!1),l.addEventListener("DOMContentLoaded",function(){for(var e,t,s=l.querySelectorAll("iframe.wp-embedded-content"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute("data-secret"))||(t=Math.random().toString(36).substring(2,12),e.src+="#?secret="+t,e.setAttribute("data-secret",t)),e.contentWindow.postMessage({message:"ready",secret:t},"*")},!1)))}(window,document); //# sourceURL=https://podcast.biomeder.com/wp-includes/js/wp-embed.min.js </script>

歐盟醫療器材法規（MDR/IVDR）近期修法草案所引發的各方利益角力與實務挑戰。這集討論核心在於業界遊說如何推動法規鬆綁，包括簡化文件審查、開放遠端稽核，以及針對突破性器材與孤兒器材建立明確定義以加速上市流程。

科學

EP255-在利益與良心之間? 歐盟 MDR 五年之約的存廢大戰

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<blockquote class="wp-embedded-content" data-secret="GUpoeMkl5C"><a href="https://podcast.biomeder.com/episodes/eu-mdr-5-year-certificate-validity-debate/">EP255-在利益與良心之間? 歐盟 MDR 五年之約的存廢大戰</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://podcast.biomeder.com/episodes/eu-mdr-5-year-certificate-validity-debate/embed/#?secret=GUpoeMkl5C" width="500" height="350" title="EP255-在利益與良心之間? 歐盟 MDR 五年之約的存廢大戰 &#8212; 生醫人生旅歷" data-secret="GUpoeMkl5C" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script> /*! This file is auto-generated */ !function(d,l){"use strict";l.querySelector&&d.addEventListener&&"undefined"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!/[^a-zA-Z0-9]/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret="'+t.secret+'"]'),o=l.querySelectorAll('blockquote[data-secret="'+t.secret+'"]'),c=new RegExp("^https?:$","i"),i=0;i<o.length;i++)o[i].style.display="none";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute("style"),"height"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):"link"===t.message&&(r=new URL(s.getAttribute("src")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener("message",d.wp.receiveEmbedMessage,!1),l.addEventListener("DOMContentLoaded",function(){for(var e,t,s=l.querySelectorAll("iframe.wp-embedded-content"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute("data-secret"))||(t=Math.random().toString(36).substring(2,12),e.src+="#?secret="+t,e.setAttribute("data-secret",t)),e.contentWindow.postMessage({message:"ready",secret:t},"*")},!1)))}(window,document); //# sourceURL=https://podcast.biomeder.com/wp-includes/js/wp-embed.min.js </script>

這集內容涵蓋閒聊在瑞典的生活觀察、氣候變遷的影響，以及專業領域中歐盟醫材法規（MDR/IVDR）的變革與現況。