{"id":8872,"date":"2025-10-08T12:37:40","date_gmt":"2025-10-08T09:37:40","guid":{"rendered":"https:\/\/jordan-cardiac.org\/?p=8872"},"modified":"2025-10-08T12:37:40","modified_gmt":"2025-10-08T09:37:40","slug":"esc-leads-push-for-stronger-ce-mark-evidence-on-high-risk-devices","status":"publish","type":"post","link":"https:\/\/jordan-cardiac.org\/en\/esc-leads-push-for-stronger-ce-mark-evidence-on-high-risk-devices\/","title":{"rendered":"ESC Leads Push for Stronger CE-Mark Evidence on High-Risk Devices"},"content":{"rendered":"<div>ESC Leads Push for Stronger CE-Mark Evidence on High-Risk Devices<\/div>\n<div><\/div>\n<div>Source: The Lancet , published online September 2025 \u2013 recommendations by ESC<\/div>\n<div><\/div>\n<div>Keynotes :<\/div>\n<div>1-Background<\/div>\n<div><span> \u2022 Europe\u2019s CE Mark approval requires only safety and minimal efficacy, unlike the U.S. FDA which demands strong clinical proof.<\/span><\/div>\n<div><span> \u2022 Cardiologists are urging tougher rules to protect patients and improve evidence quality.<\/span><\/div>\n<div><\/div>\n<div>2-ESC Initiative:<\/div>\n<div>European Society of Cardiology (ESC), published new recommendations in The Lancet (September 2025).<\/div>\n<div><\/div>\n<div>3-Key Findings<\/div>\n<div><span> \u2022 Many high-risk devices (cardiac, orthopedic, diabetic) entered the EU market without robust trials.<\/span><\/div>\n<div><span> \u2022 The report calls for:<\/span><\/div>\n<div><span> \u2022 Randomized controlled trials, including sham-controlled designs.<\/span><\/div>\n<div><span> \u2022 Transparent data sharing and registry-based long-term follow-up.<\/span><\/div>\n<div><span> \u2022 Clearer, science-based definitions of clinical evidence.<\/span><\/div>\n<div><\/div>\n<div>4-Expert Opinion<\/div>\n<div><span> \u2022 Prof. Alan Fraser: The EU must move from legal interpretation to clinical science.<\/span><\/div>\n<div><span> \u2022 Prof. Thomas L\u00fcscher: Reliable, randomized evidence is essential for safety and innovation.<\/span><\/div>\n<div><\/div>\n<div><a href=\"http:\/\/www.thelancet.com\/journals\/LANEPE\/article\/PIIS2666-7762(25)00252-2\/fulltext\">http:\/\/www.thelancet.com\/journals\/LANEPE\/article\/PIIS2666-7762(25)00252-2\/fulltext<\/a><\/div>\n<div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>ESC Leads Push for Stronger CE-Mark Evidence on High-Risk Devices Source: The Lancet , published online September 2025 \u2013 recommendations by ESC Keynotes : 1-Background \u2022 Europe\u2019s CE Mark approval requires only safety and minimal efficacy, unlike the U.S. FDA which demands strong clinical proof. \u2022 Cardiologists are urging tougher rules to protect patients and [&hellip;]<\/p>\n","protected":false},"author":145,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-8872","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/8872","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/users\/145"}],"replies":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/comments?post=8872"}],"version-history":[{"count":1,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/8872\/revisions"}],"predecessor-version":[{"id":8873,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/8872\/revisions\/8873"}],"wp:attachment":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/media?parent=8872"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/categories?post=8872"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/tags?post=8872"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}