{"id":7795,"date":"2024-02-06T11:18:42","date_gmt":"2024-02-06T10:18:42","guid":{"rendered":"https:\/\/www.entecerma.it\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/"},"modified":"2024-02-06T11:26:43","modified_gmt":"2024-02-06T10:26:43","slug":"ecm-issues-new-certificates-under-the-eu-medical-device-regulation","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/","title":{"rendered":"ECM issues new certificates under the EU Medical Device Regulation"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><strong><em>We are excited to announce the issuance of another certificate in accordance with Regulation (EU) 2017\/745 (MDR).<\/em><\/strong><\/h2>\n\n<p>In line with our mission to ensure professional and reliable medical device conformity assessment services for manufacturers, ECM issues another certificate under MDR 2017\/745. This further step highlights our ongoing commitment to excellence and quality services for medtech companies.<\/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-1213356bc3ec76eefa7bf6d47bf65f48\" style=\"color:#085f9b\"><strong>OUR EXPERIENCE SERVING BUSINESSES<\/strong><\/h3>\n\n<p>As <a href=\"https:\/\/www.entecerma.it\/en\/activities\/certifications\/product-and-service\/medical-devices-regulation-eu-2017-745\/\" target=\"_blank\" rel=\"noopener\"><strong>European Notified Body No. 1282<\/strong><\/a>, we have consolidated our <strong>international reputation<\/strong>, ensuring that our services remain at the forefront to meet evolving regulatory challenges. This requires ongoing updates, active participation in European institutional meetings, and engagement with stakeholders on key regulatory focuses.<\/p>\n\n<p>We proudly affirm that our <strong>team of experts<\/strong> possesses the skills and experience necessary to ensure a thorough and constant commitment to the medical device conformity verification process.<\/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-3f462b9a4fe5a4d56d6d7ffbb2dfedf2\" style=\"color:#085f9b\"><strong>THE IMPORTANCE OF TIMELINESS<\/strong><\/h3>\n\n<p>Within the next 4 months, thousands of MDD certificates will expire. To extend their validity, it is essential for manufacturers to formally <strong>apply for certification<\/strong> with a Notified Body under the Medical Device Regulation (MDR) <strong>by 26<\/strong> <strong>May 2024<\/strong>.<\/p>\n\n<p>Considering the longer timelines of the MDR certification process and the significant increase in requests, Notified Bodies are quickly approaching their maximum capacity for new customers. Therefore, manufacturers must <strong>act promptly<\/strong> to ensure certification applications are processed as soon as possible.<\/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-8b6777064e08decce15740429088ad3d\" style=\"color:#085f9b\"><strong>ECM ACCEPTS NEW CERTIFICATION APPLICATIONS<\/strong><\/h3>\n\n<p><strong>The ECM team is ready to welcome new certification applications!<\/strong> The issuance of new MDR certificates marks a significant stride in our mission to assess medical devices destined for the EU market. This initiative is crucial to prevent shortages of medical devices in the EU market and to verify their safety and compliance.<\/p>\n\n<p><strong>Contact us today<\/strong> to start the certification process of your medical device at:<\/p>\n\n<p>Diego Stevanella \u2013 Sales Manager ECM <a href=\"mailto:diego.s@entecerma.it\">diego.s@entecerma.it<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>We are excited to announce the issuance of another certificate in accordance with Regulation (EU)&#8230;<\/p>\n","protected":false},"author":2,"featured_media":7791,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[949,282,128,950,1166,404,123,924,1237,180],"class_list":["post-7795","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-certificazione-mdr-en","tag-dispositivi-medici-en","tag-mdr-2017-745-en","tag-mdr-certification-en","tag-mdr-notified-body-en","tag-medical-device-regulation-en","tag-medical-devices-en","tag-mercato-ue-en","tag-organismo-notificato-mdr-en","tag-regulatory-affairs-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ECM issues new certificates under the EU Medical Device Regulation - Ente Certificazione Macchine<\/title>\n<meta name=\"description\" content=\"We are excited to announce the issuance of another certificate in accordance with Regulation (EU) 2017\/745 (MDR).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ECM issues new certificates under the EU Medical Device Regulation - Ente Certificazione Macchine\" \/>\n<meta property=\"og:description\" content=\"We are excited to announce the issuance of another certificate in accordance with Regulation (EU) 2017\/745 (MDR).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/\" \/>\n<meta property=\"og:site_name\" content=\"Ente Certificazione Macchine\" \/>\n<meta property=\"article:published_time\" content=\"2024-02-06T10:18:42+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-02-06T10:26:43+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2024\/02\/2024.02_ECM-emette-nuovi-certificati-ai-sensi-del-Regolamento-MDR.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"450\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"entecerma\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"entecerma\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\\\/\"},\"author\":{\"name\":\"entecerma\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/#\\\/schema\\\/person\\\/b2c76707e5a5c46c1c3cf1e617980f5e\"},\"headline\":\"ECM issues new certificates under the EU Medical Device Regulation\",\"datePublished\":\"2024-02-06T10:18:42+00:00\",\"dateModified\":\"2024-02-06T10:26:43+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\\\/\"},\"wordCount\":299,\"image\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.entecerma.it\\\/wp-content\\\/uploads\\\/2024\\\/02\\\/2024.02_ECM-emette-nuovi-certificati-ai-sensi-del-Regolamento-MDR.png\",\"keywords\":[\"certificazione MDR\",\"dispositivi medici\",\"MDR 2017\\\/745\",\"MDR certification\",\"MDR Notified Body\",\"Medical Device Regulation\",\"medical devices\",\"mercato UE\",\"Organismo Notificato MDR\",\"regulatory affairs\"],\"articleSection\":[\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\\\/\",\"url\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\\\/\",\"name\":\"ECM issues new certificates under the EU Medical Device Regulation - Ente Certificazione Macchine\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.entecerma.it\\\/wp-content\\\/uploads\\\/2024\\\/02\\\/2024.02_ECM-emette-nuovi-certificati-ai-sensi-del-Regolamento-MDR.png\",\"datePublished\":\"2024-02-06T10:18:42+00:00\",\"dateModified\":\"2024-02-06T10:26:43+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/#\\\/schema\\\/person\\\/b2c76707e5a5c46c1c3cf1e617980f5e\"},\"description\":\"We are excited to announce the issuance of another certificate in accordance with Regulation (EU) 2017\\\/745 (MDR).\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.entecerma.it\\\/en\\\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.entecerma.it\\\/wp-content\\\/uploads\\\/2024\\\/02\\\/2024.02_ECM-emette-nuovi-certificati-ai-sensi-del-Regolamento-MDR.png\",\"contentUrl\":\"https:\\\/\\\/www.entecerma.it\\\/wp-content\\\/uploads\\\/2024\\\/02\\\/2024.02_ECM-emette-nuovi-certificati-ai-sensi-del-Regolamento-MDR.png\",\"width\":800,\"height\":450},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"ECM issues new certificates under the EU Medical Device Regulation\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/\",\"name\":\"Ente Certificazione Macchine\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/#\\\/schema\\\/person\\\/b2c76707e5a5c46c1c3cf1e617980f5e\",\"name\":\"entecerma\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/99fcbedcaa1f19ae59344cedcf7d01cdc9db104925424ad87bc5a34b478ec6c8?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/99fcbedcaa1f19ae59344cedcf7d01cdc9db104925424ad87bc5a34b478ec6c8?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/99fcbedcaa1f19ae59344cedcf7d01cdc9db104925424ad87bc5a34b478ec6c8?s=96&d=mm&r=g\",\"caption\":\"entecerma\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"ECM issues new certificates under the EU Medical Device Regulation - Ente Certificazione Macchine","description":"We are excited to announce the issuance of another certificate in accordance with Regulation (EU) 2017\/745 (MDR).","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/","og_locale":"en_US","og_type":"article","og_title":"ECM issues new certificates under the EU Medical Device Regulation - Ente Certificazione Macchine","og_description":"We are excited to announce the issuance of another certificate in accordance with Regulation (EU) 2017\/745 (MDR).","og_url":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/","og_site_name":"Ente Certificazione Macchine","article_published_time":"2024-02-06T10:18:42+00:00","article_modified_time":"2024-02-06T10:26:43+00:00","og_image":[{"width":800,"height":450,"url":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2024\/02\/2024.02_ECM-emette-nuovi-certificati-ai-sensi-del-Regolamento-MDR.png","type":"image\/png"}],"author":"entecerma","twitter_card":"summary_large_image","twitter_misc":{"Written by":"entecerma","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/#article","isPartOf":{"@id":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/"},"author":{"name":"entecerma","@id":"https:\/\/www.entecerma.it\/en\/#\/schema\/person\/b2c76707e5a5c46c1c3cf1e617980f5e"},"headline":"ECM issues new certificates under the EU Medical Device Regulation","datePublished":"2024-02-06T10:18:42+00:00","dateModified":"2024-02-06T10:26:43+00:00","mainEntityOfPage":{"@id":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/"},"wordCount":299,"image":{"@id":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/#primaryimage"},"thumbnailUrl":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2024\/02\/2024.02_ECM-emette-nuovi-certificati-ai-sensi-del-Regolamento-MDR.png","keywords":["certificazione MDR","dispositivi medici","MDR 2017\/745","MDR certification","MDR Notified Body","Medical Device Regulation","medical devices","mercato UE","Organismo Notificato MDR","regulatory affairs"],"articleSection":["News"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/","url":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/","name":"ECM issues new certificates under the EU Medical Device Regulation - Ente Certificazione Macchine","isPartOf":{"@id":"https:\/\/www.entecerma.it\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/#primaryimage"},"image":{"@id":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/#primaryimage"},"thumbnailUrl":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2024\/02\/2024.02_ECM-emette-nuovi-certificati-ai-sensi-del-Regolamento-MDR.png","datePublished":"2024-02-06T10:18:42+00:00","dateModified":"2024-02-06T10:26:43+00:00","author":{"@id":"https:\/\/www.entecerma.it\/en\/#\/schema\/person\/b2c76707e5a5c46c1c3cf1e617980f5e"},"description":"We are excited to announce the issuance of another certificate in accordance with Regulation (EU) 2017\/745 (MDR).","breadcrumb":{"@id":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/#primaryimage","url":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2024\/02\/2024.02_ECM-emette-nuovi-certificati-ai-sensi-del-Regolamento-MDR.png","contentUrl":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2024\/02\/2024.02_ECM-emette-nuovi-certificati-ai-sensi-del-Regolamento-MDR.png","width":800,"height":450},{"@type":"BreadcrumbList","@id":"https:\/\/www.entecerma.it\/en\/ecm-issues-new-certificates-under-the-eu-medical-device-regulation\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.entecerma.it\/en\/"},{"@type":"ListItem","position":2,"name":"ECM issues new certificates under the EU Medical Device Regulation"}]},{"@type":"WebSite","@id":"https:\/\/www.entecerma.it\/en\/#website","url":"https:\/\/www.entecerma.it\/en\/","name":"Ente Certificazione Macchine","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.entecerma.it\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.entecerma.it\/en\/#\/schema\/person\/b2c76707e5a5c46c1c3cf1e617980f5e","name":"entecerma","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/99fcbedcaa1f19ae59344cedcf7d01cdc9db104925424ad87bc5a34b478ec6c8?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/99fcbedcaa1f19ae59344cedcf7d01cdc9db104925424ad87bc5a34b478ec6c8?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/99fcbedcaa1f19ae59344cedcf7d01cdc9db104925424ad87bc5a34b478ec6c8?s=96&d=mm&r=g","caption":"entecerma"}}]}},"_links":{"self":[{"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/posts\/7795","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/comments?post=7795"}],"version-history":[{"count":3,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/posts\/7795\/revisions"}],"predecessor-version":[{"id":7800,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/posts\/7795\/revisions\/7800"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/media\/7791"}],"wp:attachment":[{"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/media?parent=7795"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/categories?post=7795"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/tags?post=7795"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}