{"id":5877,"date":"2022-09-02T15:00:23","date_gmt":"2022-09-02T13:00:23","guid":{"rendered":"https:\/\/www.entecerma.it\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/"},"modified":"2022-09-02T15:05:25","modified_gmt":"2022-09-02T13:05:25","slug":"medical-device-regulation-eu-2017-745-ecm-on-the-finish-line","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/","title":{"rendered":"Medical Device Regulation (EU) 2017\/745: ECM on the finish line"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><strong><em>ECM enters the final stage for designation as Notified Body for the new European Medical Device Regulation (MDR)<\/em><\/strong><\/h2>\n\n<p>After a long and thorough evaluation process involving the European Commission, the Italian Ministry of Health and Accredia, <strong>Ente Certificazione Macchine<\/strong> is getting ready to be designated as <strong>Notified Body for Regulation (EU) 2017\/745<\/strong>.<\/p>\n\n<p>ECM has entered the final stage required to obtain the designation as Notified Body that will lead, in a <strong>short time<\/strong>, to the publication on the European Commission&#8217;s <a href=\"https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/index.cfm?fuseaction=notifiedbody.main\">NANDO<\/a> portal. Following the announcement of the designation, ECM will be able to perform the activity of <strong>conformity assessment of medical devices<\/strong> according to Regulation (EU) 2017\/745.<\/p>\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p class=\"has-white-color has-text-color has-background\" style=\"background-color:#085f9b\">Companies wishing to obtain information and join our waiting list may contact our <strong><em>Sales Manager Eng. Diego Stevanella<\/em><\/strong> at: <a href=\"mailto:diego.s@entecerma.it\">diego.s@entecerma.it<\/a> | mob. (+39) 393 2471040<\/p>\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>Following the recent important communications of the EU <em>Medical Device Coordination Group<\/em> (MDCG) addressed to manufacturers and notified bodies<\/p>\n\n<ul class=\"wp-block-list\"><li><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-11-mdcg-position-paper-notice-manufacturers-ensure-timely-compliance-mdr-requirements-2022-06-13_en\" target=\"_blank\" rel=\"noreferrer noopener\">MDCG 2022-11 Position Paper \u2013 Notice to manufacturers to ensure timely compliance with MDR requirements<\/a>;<\/li><li><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-14-transition-mdr-and-ivdr-notified-body-capacity-and-availability-medical-devices-and-2022-08-26_en\" target=\"_blank\" rel=\"noreferrer noopener\">MDCG 2022-14 Position Paper \u2013 Transition to the MDR and IVDR. Notified body capacity and availability of medical devices and IVDs<\/a>;<\/li><\/ul>\n\n<p>which underline the importance for companies to <strong>promptly comply with the MDR requirements<\/strong> to ensure that devices can continue to be placed on the market and avoid shortages of medical devices, ECM also invites manufacturers to <strong>contact us as soon as possible<\/strong> to guarantee a place on our <strong>waiting list<\/strong>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ECM enters the final stage for designation as Notified Body for the new European Medical&#8230;<\/p>\n","protected":false},"author":2,"featured_media":5873,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[128,404,123,185],"class_list":["post-5877","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-mdr-2017-745-en","tag-medical-device-regulation-en","tag-medical-devices-en","tag-organismo-notificato-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical Device Regulation (EU) 2017\/745: ECM on the finish line - Ente Certificazione Macchine<\/title>\n<meta name=\"description\" content=\"ECM enters the final stage for designation as Notified Body for the new European Medical Device Regulation (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\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Regulation (EU) 2017\/745: ECM on the finish line - Ente Certificazione Macchine\" \/>\n<meta property=\"og:description\" content=\"ECM enters the final stage for designation as Notified Body for the new European Medical Device Regulation (MDR).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/\" \/>\n<meta property=\"og:site_name\" content=\"Ente Certificazione Macchine\" \/>\n<meta property=\"article:published_time\" content=\"2022-09-02T13:00:23+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-09-02T13:05:25+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2022\/09\/2022.09.02_Medical-Device-Regulation-EU-2017745-ECM-in-dirittura-darrivo.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1600\" \/>\n\t<meta property=\"og:image:height\" content=\"900\" \/>\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\\\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\\\/\"},\"author\":{\"name\":\"entecerma\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/#\\\/schema\\\/person\\\/b2c76707e5a5c46c1c3cf1e617980f5e\"},\"headline\":\"Medical Device Regulation (EU) 2017\\\/745: ECM on the finish line\",\"datePublished\":\"2022-09-02T13:00:23+00:00\",\"dateModified\":\"2022-09-02T13:05:25+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\\\/\"},\"wordCount\":242,\"image\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.entecerma.it\\\/wp-content\\\/uploads\\\/2022\\\/09\\\/2022.09.02_Medical-Device-Regulation-EU-2017745-ECM-in-dirittura-darrivo.png\",\"keywords\":[\"MDR 2017\\\/745\",\"Medical Device Regulation\",\"medical devices\",\"Organismo Notificato\"],\"articleSection\":[\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\\\/\",\"url\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\\\/\",\"name\":\"Medical Device Regulation (EU) 2017\\\/745: ECM on the finish line - Ente Certificazione Macchine\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.entecerma.it\\\/wp-content\\\/uploads\\\/2022\\\/09\\\/2022.09.02_Medical-Device-Regulation-EU-2017745-ECM-in-dirittura-darrivo.png\",\"datePublished\":\"2022-09-02T13:00:23+00:00\",\"dateModified\":\"2022-09-02T13:05:25+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/#\\\/schema\\\/person\\\/b2c76707e5a5c46c1c3cf1e617980f5e\"},\"description\":\"ECM enters the final stage for designation as Notified Body for the new European Medical Device Regulation (MDR).\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.entecerma.it\\\/en\\\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.entecerma.it\\\/wp-content\\\/uploads\\\/2022\\\/09\\\/2022.09.02_Medical-Device-Regulation-EU-2017745-ECM-in-dirittura-darrivo.png\",\"contentUrl\":\"https:\\\/\\\/www.entecerma.it\\\/wp-content\\\/uploads\\\/2022\\\/09\\\/2022.09.02_Medical-Device-Regulation-EU-2017745-ECM-in-dirittura-darrivo.png\",\"width\":1600,\"height\":900},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Medical Device Regulation (EU) 2017\\\/745: ECM on the finish line\"}]},{\"@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":"Medical Device Regulation (EU) 2017\/745: ECM on the finish line - Ente Certificazione Macchine","description":"ECM enters the final stage for designation as Notified Body for the new European Medical Device Regulation (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\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/","og_locale":"en_US","og_type":"article","og_title":"Medical Device Regulation (EU) 2017\/745: ECM on the finish line - Ente Certificazione Macchine","og_description":"ECM enters the final stage for designation as Notified Body for the new European Medical Device Regulation (MDR).","og_url":"https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/","og_site_name":"Ente Certificazione Macchine","article_published_time":"2022-09-02T13:00:23+00:00","article_modified_time":"2022-09-02T13:05:25+00:00","og_image":[{"width":1600,"height":900,"url":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2022\/09\/2022.09.02_Medical-Device-Regulation-EU-2017745-ECM-in-dirittura-darrivo.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\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/#article","isPartOf":{"@id":"https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/"},"author":{"name":"entecerma","@id":"https:\/\/www.entecerma.it\/en\/#\/schema\/person\/b2c76707e5a5c46c1c3cf1e617980f5e"},"headline":"Medical Device Regulation (EU) 2017\/745: ECM on the finish line","datePublished":"2022-09-02T13:00:23+00:00","dateModified":"2022-09-02T13:05:25+00:00","mainEntityOfPage":{"@id":"https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/"},"wordCount":242,"image":{"@id":"https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/#primaryimage"},"thumbnailUrl":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2022\/09\/2022.09.02_Medical-Device-Regulation-EU-2017745-ECM-in-dirittura-darrivo.png","keywords":["MDR 2017\/745","Medical Device Regulation","medical devices","Organismo Notificato"],"articleSection":["News"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/","url":"https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/","name":"Medical Device Regulation (EU) 2017\/745: ECM on the finish line - Ente Certificazione Macchine","isPartOf":{"@id":"https:\/\/www.entecerma.it\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/#primaryimage"},"image":{"@id":"https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/#primaryimage"},"thumbnailUrl":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2022\/09\/2022.09.02_Medical-Device-Regulation-EU-2017745-ECM-in-dirittura-darrivo.png","datePublished":"2022-09-02T13:00:23+00:00","dateModified":"2022-09-02T13:05:25+00:00","author":{"@id":"https:\/\/www.entecerma.it\/en\/#\/schema\/person\/b2c76707e5a5c46c1c3cf1e617980f5e"},"description":"ECM enters the final stage for designation as Notified Body for the new European Medical Device Regulation (MDR).","breadcrumb":{"@id":"https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/#primaryimage","url":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2022\/09\/2022.09.02_Medical-Device-Regulation-EU-2017745-ECM-in-dirittura-darrivo.png","contentUrl":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2022\/09\/2022.09.02_Medical-Device-Regulation-EU-2017745-ECM-in-dirittura-darrivo.png","width":1600,"height":900},{"@type":"BreadcrumbList","@id":"https:\/\/www.entecerma.it\/en\/medical-device-regulation-eu-2017-745-ecm-on-the-finish-line\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.entecerma.it\/en\/"},{"@type":"ListItem","position":2,"name":"Medical Device Regulation (EU) 2017\/745: ECM on the finish line"}]},{"@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\/5877","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=5877"}],"version-history":[{"count":1,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/posts\/5877\/revisions"}],"predecessor-version":[{"id":5878,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/posts\/5877\/revisions\/5878"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/media\/5873"}],"wp:attachment":[{"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/media?parent=5877"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/categories?post=5877"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/tags?post=5877"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}