{"id":9161,"date":"2025-02-27T12:03:25","date_gmt":"2025-02-27T11:03:25","guid":{"rendered":"https:\/\/www.entecerma.it\/clinical-evaluation-in-the-mdr-interest-and-participation-in-the-webinar-held-by-ecm\/"},"modified":"2025-02-27T12:09:54","modified_gmt":"2025-02-27T11:09:54","slug":"clinical-evaluation-in-the-mdr-interest-and-participation-in-the-webinar-held-by-ecm","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/clinical-evaluation-in-the-mdr-interest-and-participation-in-the-webinar-held-by-ecm\/","title":{"rendered":"Clinical Evaluation in the MDR: interest and participation in the Webinar held by ECM"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><strong><em>The webinar on Clinical Evaluation in the MDR organised by RAPS Quebec LNG attracted wide participation, confirming the interest in key topics related to compliance with regulatory requirements.<\/em><\/strong><\/h2>\n\n<p>On 24 February 2025, ECM participated as the sole speaker in the webinar <em>\u201c<\/em><a href=\"https:\/\/www.raps.org\/events\/quebec-lng-virtual-event-clinical-evaluation-under-mdr-explained-by-a-notified-body\" target=\"_blank\" rel=\"noopener\"><em>Clinical Evaluation under MDR explained by a Notified Body<\/em><\/a><em>\u201d,<\/em> organized by <strong>RAPS Quebec Local Networking Group<\/strong>. The initiative generated strong interest among manufacturers and industry professionals, with over 120 registrants and active participation that remained consistent until the end of the event. The webinar also generated a large number of questions from the audience, confirming the high level of interest in the topics discussed.<\/p>\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-df72578a1d0fafd95c17537005aa3365\" style=\"color:#085f9b\"><strong>TECHNICAL INSIGHTS ON CLINICAL EVALUATION UNDER MDR<\/strong><\/h3>\n\n<p>The webinar delved into some key aspects related to the <strong>clinical evaluation process<\/strong> of MDR 2015\/745. In particular, Riccardo Persia, Clinical Manager at ECM, explained the fundamentals and methodological principles underlying the clinical evaluation process:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Article 61(10) of the MDR and the regulatory obligations for demonstrating compliance with general safety and performance requirements in the absence of clinical data;<\/li>\n\n\n\n<li>The provisions of the MDCG 2024-10 guideline regarding the clinical evaluation of \u2018orphan\u2019 medical devices.<\/li>\n<\/ul>\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-31c1cf1b6562958a3f3cbb6ddb42b637\" style=\"color:#085f9b\"><strong>ONGOING INTEREST IN COMPLEX ISSUES<\/strong><\/h3>\n\n<p>The high number of registrants and the level of interest among participants demonstrate how essential it is to address the more complex issues related to clinical evaluation under MDR in a clear and professional way. ECM\u2019s commitment as a <a href=\"https:\/\/www.entecerma.it\/en\/activities\/certifications\/product-and-service\/medical-devices-regulation-eu-2017-745\/\" target=\"_blank\" rel=\"noopener\">Notified Body<\/a> also involves providing, in addition to certification activities, <strong>accurate and updated information<\/strong> to ensure companies have a better understanding of regulatory complexities.<\/p>\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-a254115014292c4e19c8661e733c05a2\" style=\"color:#085f9b\"><strong>A REFERENCE EVENT FOR THE SECTOR<\/strong><\/h3>\n\n<p>Events like this represent a key opportunity for medical device manufacturers and industry professionals, offering <strong>concrete tools<\/strong> <strong>to better understand<\/strong> and optimally apply regulatory requirements. The success of this initiative highlights the importance of continuing to promote moments of discussion and in-depth exploration of clinical evaluation and other MDR requirements.<\/p>\n\n<p>To stay updated on upcoming events and topics of greatest interest in the certification sector, follow us on <a href=\"https:\/\/www.linkedin.com\/showcase\/ecm-notified-body-medical-device\/\" target=\"_blank\" rel=\"noopener\">LinkedIn<\/a> or contact our Sales team:<\/p>\n\n<p>Diego Stevanella: <a href=\"mailto:diego.s@entecerma.it\">diego.s@entecerma.it<\/a><\/p>\n\n<p>Marzia Pellegrini: <a href=\"mailto:marzia.p@entecerma.it\">marzia.p@entecerma.it<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The webinar on Clinical Evaluation in the MDR organised by RAPS Quebec LNG attracted wide&#8230;<\/p>\n","protected":false},"author":2,"featured_media":9159,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12,13,2],"tags":[949,1585,282,1538,128,569,123,367,189,1587,552,1608],"class_list":["post-9161","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-history-en","category-events","category-news","tag-certificazione-mdr-en","tag-clinical-evaluation-en","tag-dispositivi-medici-en","tag-ecm-for-medical-devices-en","tag-mdr-2017-745-en","tag-medical-device-certification-en","tag-medical-devices-en","tag-notified-body-en","tag-raps-en","tag-raps-quebec-en","tag-valutazione-clinica-en","tag-webinar-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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