{"id":12010,"date":"2026-02-03T14:49:55","date_gmt":"2026-02-03T13:49:55","guid":{"rendered":"https:\/\/www.entecerma.it\/mdr-2017-745-certification-tomorrow-is-already-here\/"},"modified":"2026-02-03T15:04:55","modified_gmt":"2026-02-03T14:04:55","slug":"mdr-2017-745-certification-tomorrow-is-already-here","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/","title":{"rendered":"MDR 2017\/745 certification: tomorrow is already here"},"content":{"rendered":"\n<p>Failure to promptly comply with the requirements of the MDR Regulation\u2014which stipulates more robust technical documentation, the application of new classification rules, and a more rigorous post-market surveillance system\u2014will inevitably result in products being excluded from the European market.<\/p>\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-50dad02278cf81166e2d12c3525bc7dd\">CLASS I TO CLASS IIA (OR HIGHER) DEVICES: WHAT IS REALLY CHANGING?<\/h3>\n\n<p>With the entry into force of the MDR, many manufacturers have faced a substantial change: devices classified as Class I under the MDD are now reclassified as Class IIa, IIb, or III, with much stricter requirements.<\/p>\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-64d7ab007ab9220978654b7c3717cc20\">WHO IS INVOLVED?<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>Medical software<\/li>\n<\/ul>\n\n<ul class=\"wp-block-list\">\n<li>Reusable surgical instruments<\/li>\n<\/ul>\n\n<ul class=\"wp-block-list\">\n<li>Devices with measuring function<\/li>\n<\/ul>\n\n<ul class=\"wp-block-list\">\n<li>Long-term invasive products<\/li>\n<\/ul>\n\n<p>All typical cases of reclassification, which now require mandatory assessment by a Notified Body (NB).<\/p>\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-2ae06f9933fd79d4c13ca23695cf30c0\">HAVE YOU ALREADY SUBMITTED THE DOCUMENTATION TO YOUR NB?<\/h3>\n\n<p>With the entry into force of Regulation (EU) 2023\/607, new transitional terms have been introduced for all legacy devices, but only for those who have already started the process.<\/p>\n\n<p>Delaying submission could lead to:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>NB overload<\/li>\n\n\n\n<li>Delays in assessments<\/li>\n\n\n\n<li>Risk of not obtaining CE certification in time<\/li>\n<\/ul>\n\n<p>The right time to act is now.<br\/>Delaying means exposing yourself to regulatory uncertainties and possible interruptions in marketing.<\/p>\n\n<p>Contact us today to complete your MDR process safely, without any unexpected surprises and with the certainty of having an expert partner at your side.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Failure to promptly comply with the requirements of the MDR Regulation\u2014which stipulates more robust technical&#8230;<\/p>\n","protected":false},"author":2,"featured_media":12003,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-12010","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDR 2017\/745 certification: tomorrow is already here - Ente Certificazione Macchine<\/title>\n<meta name=\"description\" content=\"With the entry into force of Regulation (EU) 2023\/607, new transitional terms have been introduced for all legacy devices, but only for those who have already started the process. The right time to act is now. Postponing means exposing yourself to regulatory uncertainties and possible interruptions in marketing.\" \/>\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\/mdr-2017-745-certification-tomorrow-is-already-here\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR 2017\/745 certification: tomorrow is already here - Ente Certificazione Macchine\" \/>\n<meta property=\"og:description\" content=\"With the entry into force of Regulation (EU) 2023\/607, new transitional terms have been introduced for all legacy devices, but only for those who have already started the process. The right time to act is now. Postponing means exposing yourself to regulatory uncertainties and possible interruptions in marketing.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/\" \/>\n<meta property=\"og:site_name\" content=\"Ente Certificazione Macchine\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-03T13:49:55+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-03T14:04:55+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2026\/02\/MDR-time-is-over.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"1200\" \/>\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\\\/mdr-2017-745-certification-tomorrow-is-already-here\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/mdr-2017-745-certification-tomorrow-is-already-here\\\/\"},\"author\":{\"name\":\"entecerma\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/#\\\/schema\\\/person\\\/b2c76707e5a5c46c1c3cf1e617980f5e\"},\"headline\":\"MDR 2017\\\/745 certification: tomorrow is already here\",\"datePublished\":\"2026-02-03T13:49:55+00:00\",\"dateModified\":\"2026-02-03T14:04:55+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/mdr-2017-745-certification-tomorrow-is-already-here\\\/\"},\"wordCount\":224,\"image\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/mdr-2017-745-certification-tomorrow-is-already-here\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.entecerma.it\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/MDR-time-is-over.png\",\"articleSection\":[\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/mdr-2017-745-certification-tomorrow-is-already-here\\\/\",\"url\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/mdr-2017-745-certification-tomorrow-is-already-here\\\/\",\"name\":\"MDR 2017\\\/745 certification: tomorrow is already here - Ente Certificazione Macchine\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/mdr-2017-745-certification-tomorrow-is-already-here\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/mdr-2017-745-certification-tomorrow-is-already-here\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.entecerma.it\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/MDR-time-is-over.png\",\"datePublished\":\"2026-02-03T13:49:55+00:00\",\"dateModified\":\"2026-02-03T14:04:55+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/#\\\/schema\\\/person\\\/b2c76707e5a5c46c1c3cf1e617980f5e\"},\"description\":\"With the entry into force of Regulation (EU) 2023\\\/607, new transitional terms have been introduced for all legacy devices, but only for those who have already started the process. The right time to act is now. Postponing means exposing yourself to regulatory uncertainties and possible interruptions in marketing.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/mdr-2017-745-certification-tomorrow-is-already-here\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.entecerma.it\\\/en\\\/mdr-2017-745-certification-tomorrow-is-already-here\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/mdr-2017-745-certification-tomorrow-is-already-here\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.entecerma.it\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/MDR-time-is-over.png\",\"contentUrl\":\"https:\\\/\\\/www.entecerma.it\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/MDR-time-is-over.png\",\"width\":1200,\"height\":1200},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/mdr-2017-745-certification-tomorrow-is-already-here\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"MDR 2017\\\/745 certification: tomorrow is already here\"}]},{\"@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":"MDR 2017\/745 certification: tomorrow is already here - Ente Certificazione Macchine","description":"With the entry into force of Regulation (EU) 2023\/607, new transitional terms have been introduced for all legacy devices, but only for those who have already started the process. The right time to act is now. Postponing means exposing yourself to regulatory uncertainties and possible interruptions in marketing.","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\/mdr-2017-745-certification-tomorrow-is-already-here\/","og_locale":"en_US","og_type":"article","og_title":"MDR 2017\/745 certification: tomorrow is already here - Ente Certificazione Macchine","og_description":"With the entry into force of Regulation (EU) 2023\/607, new transitional terms have been introduced for all legacy devices, but only for those who have already started the process. The right time to act is now. Postponing means exposing yourself to regulatory uncertainties and possible interruptions in marketing.","og_url":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/","og_site_name":"Ente Certificazione Macchine","article_published_time":"2026-02-03T13:49:55+00:00","article_modified_time":"2026-02-03T14:04:55+00:00","og_image":[{"width":1200,"height":1200,"url":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2026\/02\/MDR-time-is-over.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\/mdr-2017-745-certification-tomorrow-is-already-here\/#article","isPartOf":{"@id":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/"},"author":{"name":"entecerma","@id":"https:\/\/www.entecerma.it\/en\/#\/schema\/person\/b2c76707e5a5c46c1c3cf1e617980f5e"},"headline":"MDR 2017\/745 certification: tomorrow is already here","datePublished":"2026-02-03T13:49:55+00:00","dateModified":"2026-02-03T14:04:55+00:00","mainEntityOfPage":{"@id":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/"},"wordCount":224,"image":{"@id":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/#primaryimage"},"thumbnailUrl":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2026\/02\/MDR-time-is-over.png","articleSection":["News"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/","url":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/","name":"MDR 2017\/745 certification: tomorrow is already here - Ente Certificazione Macchine","isPartOf":{"@id":"https:\/\/www.entecerma.it\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/#primaryimage"},"image":{"@id":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/#primaryimage"},"thumbnailUrl":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2026\/02\/MDR-time-is-over.png","datePublished":"2026-02-03T13:49:55+00:00","dateModified":"2026-02-03T14:04:55+00:00","author":{"@id":"https:\/\/www.entecerma.it\/en\/#\/schema\/person\/b2c76707e5a5c46c1c3cf1e617980f5e"},"description":"With the entry into force of Regulation (EU) 2023\/607, new transitional terms have been introduced for all legacy devices, but only for those who have already started the process. The right time to act is now. Postponing means exposing yourself to regulatory uncertainties and possible interruptions in marketing.","breadcrumb":{"@id":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/#primaryimage","url":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2026\/02\/MDR-time-is-over.png","contentUrl":"https:\/\/www.entecerma.it\/wp-content\/uploads\/2026\/02\/MDR-time-is-over.png","width":1200,"height":1200},{"@type":"BreadcrumbList","@id":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-tomorrow-is-already-here\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.entecerma.it\/en\/"},{"@type":"ListItem","position":2,"name":"MDR 2017\/745 certification: tomorrow is already here"}]},{"@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\/12010","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=12010"}],"version-history":[{"count":3,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/posts\/12010\/revisions"}],"predecessor-version":[{"id":12013,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/posts\/12010\/revisions\/12013"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/media\/12003"}],"wp:attachment":[{"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/media?parent=12010"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/categories?post=12010"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.entecerma.it\/en\/wp-json\/wp\/v2\/tags?post=12010"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}