{"id":14707,"date":"2020-06-17T17:43:36","date_gmt":"2020-06-17T15:43:36","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=14707"},"modified":"2020-06-17T17:43:36","modified_gmt":"2020-06-17T15:43:36","slug":"mdr-2017-745-medical-devices-regulation-the-major-changes","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/","title":{"rendered":"MDR 2017\/745 Medical Devices Regulation: the major changes"},"content":{"rendered":"\n<p>The new <strong>MDR (EU) 2017\/745 <\/strong>entered into force on May 26, 2017 by repealing the Directives 90\/385\/EEC (AIMDD) and 93\/42\/EEC (MDD). <\/p>\n\n\n\n<p>Before discovering all the most relevant features of the MDR Medical Devices Regulation 2017\/745, we remember the <strong>most important deadlines.<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/Regolamento-Dispositivi-Medici-mdr-2017-745-1024x535.png\" alt=\"MDR 2017\/745 Medical Devices Regulation\" class=\"wp-image-14747\"\/><\/figure>\n\n\n\n<ul class=\"wp-block-list\"><li>The <strong>MDR 2017\/745 full application<\/strong> date was recently extended to <strong>May 26, 2021<\/strong> due to the Coronavirus emergency. <\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>From <strong>May 27, 2024<\/strong> all the MDD\/AIMDD Certificates will lose validity and\nthe MDR 2027\/745 will enter into force for the class I medical devices\nrequiring a Notified Body. <\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>From <strong>May 27, 2025<\/strong>, the devices released in accordance with the MDD\/AIMDD will no longer be made available on the market. <\/li><\/ul>\n\n\n\n<p>Therefore, this is the <strong>right time <\/strong>to address in time the new\nand more restrictive obligations of the <strong>MDR\n2017\/745 Medical Devices Regulation.<\/strong><\/p>\n\n\n\n<p>As it will become clearer in this\narticle, it is necessary to organize now in order to <strong>implement in time the new necessary processes, to increase and qualify\nthe staff company<\/strong> appointed to the MDR Certification and eventually, to\nestablish a <strong>relationship with strategic\nconsultants specialized<\/strong> in EC Certification.&nbsp;&nbsp; &nbsp;&nbsp;<strong>&nbsp;&nbsp;<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Why the MDR 2017\/745? <\/strong><\/h3>\n\n\n\n<p>Both the Council\nand the European Parliament highlight the need to adapt the legislation on\nmedical devices to the <strong>needs of the\nfuture <\/strong>in such a way as to provide an <strong>appropriate,\nrobust, transparent and sustainable regulatory framework. <\/strong><\/p>\n\n\n\n<p>That\u2019s why the <strong>MDR 2017\/745 Medical Devices Regulation <\/strong>does not simply supplements previous\nDirectives with amendments, but it was created as a real <strong>new Certification<\/strong> that provides for much stricter\nrequirements and measures more in line with the evolution of the global medical\ndevice market. <\/p>\n\n\n\n<p>Specifically,\nhere are some of the most important objectives of the new MDR 2017\/745: <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>To resolve differences in the various national regulatory systems <\/strong>between the different EU member States;<\/li><li>To strengthen<strong> the monitoring of holdings by the Notified\nBodies;<\/strong><\/li><li><strong>To strengthen the post-market surveillance <\/strong><\/li><li><strong>To better identify and trace medical devices; <\/strong><\/li><li>To cope with the need <strong>to quickly market the most innovative\nproducts that use hybrid technologies<\/strong>. <\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>MDR 2017\/745: everything more complicated<\/strong> <\/h3>\n\n\n\n<p>The new <strong>MDR 2017\/745 Medical Devices Regulation <\/strong>contains <strong>many novelties <\/strong>and at the same time <strong>inconsistencies and gaps <\/strong>which make its implementation particularly\ncomplex. <\/p>\n\n\n\n<p>Firstly, the <strong>requirements <\/strong>content in the <strong>MDR\n<\/strong>are more than those content in the MDD and they concern both the <strong>product <\/strong>and the <strong>quality system. <\/strong><\/p>\n\n\n\n<p>Moreover, implementing requirements\nrequires much <strong>more evidence and\ntechnical documentation<\/strong>. <\/p>\n\n\n\n<p>Consequently, in the implementation of\nthe <strong>MDR 2017\/745 Medical Devices\nRegulation, <\/strong>they will inevitably be favoured <strong>large organisations that can invest in the strengthening and training\nof human resources<\/strong> and that have <strong>the\nability to handle complex amendments<\/strong>, possibly with the help of strategic\nconsultants outside the company. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>The main innovations of the EU Regulation 2017\/745<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>New and <\/strong>stricter<strong> classification rules for medical devices <\/strong>and modification of same MDD rules.<\/li><li>Definition of the role and responsibilities of the Economic Operators involved in the import and distribution of medical devices: <strong>Manufacturer, Authorised Representative, Importer and Distributor. <\/strong>For each of these subjects are provided specific requirements. <\/li><li>Obligation in the companies of medical devices of the <strong>Person Responsible for compliance with the MDR 2017\/745 Medical Devices Regulation. <\/strong>The Person Responsible shell: control the conformity of the device according to the Company Quality System before the device is released, verify that the technical documentation and the declaration of conformity are present and updated, ensure that post-market surveillance requirements and reporting requirements are met. Very important: the Person Responsible must possess the<strong> essential requirements<\/strong> that certify specific competences on the EU 2017\/745 Regulation. <\/li><li>Greater importance to <strong>Clinical Evaluation. <\/strong><\/li><li><strong>Stricter post-market surveillance and vigilance. <\/strong><\/li><li>More <strong>technical documentation <\/strong>to be produced. <\/li><li>Device traceability with the creation of the <strong>UDI <\/strong>(Unique Device Identification) <strong>system. <\/strong><\/li><li>Use of <strong>EUDAMED <\/strong>to collect device information in a single European database. <\/li><li>Simplification of <strong>conformity assessment <\/strong>procedures.<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>5 tips to prepare for the new MDR (EU) 2017\/745 Regulation<\/strong><\/h3>\n\n\n\n<ol class=\"wp-block-list\"><li><strong>Select <\/strong>the list of medical devices, eliminating what represents a dispersion of resources and does not allow to re-enter the investment.<\/li><li>Consider <strong>longer times for the <em>time to market <\/em><\/strong>of new and modified medical devices. <\/li><li><strong>Strengthen the<\/strong> <strong>Quality\/Regulatory Affairs function <\/strong>and determine who can play the role of <strong>Responsible Person<\/strong> in the company. <\/li><li><strong>Involve all the business functions <\/strong>in the implementation of competence requirements(e.g. PMS). <\/li><li>Rely on <strong>expert consultants<\/strong> able to guide company strategy and to plan the necessary actions, optimizing time and costs, avoiding mistakes or to delay its presence on European markets. Thema offers <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">strategic-regulatory consulting services<\/a> and <a href=\"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/\">CE certification support<\/a> of Medical devices and IVD. Thema strategic consultants are ready to support companies in the process of adapting to the new MDR 2017\/745 Medical Devices Regulation. <\/li><\/ol>\n\n\n\n<p>To know what we can do for your Company, contact us! <a href=\"mailto:sales@thema-group.it\">sales@thema-group.it<\/a><\/p>\n\n\n\n<p>Are you an <strong>Economic Operator<\/strong> who desires to know in detail the <strong>new obligations<\/strong> under the <strong>MDR (EU) 2017\/745<\/strong>? <a href=\"https:\/\/www.thema-med.com\/en\/factsheet-for-authorised-representatives-importers-and-distributors-of-medical-devices-and-in-vitro-diagnostic-medical-devices\/\">Download our White Paper!<\/a><\/p>\n\n\n\n<p>Do you want a <strong>quick solution <\/strong>to set independently the first essential actions for Manufacturer, Authorised Representative, Importer and Distributor? Discover the <a href=\"https:\/\/www.thema-med.com\/en\/services\/new-mdr-emergency-kit\/\">MDR Emergency Kit!<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The new MDR (EU) 2017\/745 entered into force on May 26, 2017 by repealing the Directives 90\/385\/EEC (AIMDD) and 93\/42\/EEC (MDD).  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[13],"tags":[],"class_list":["post-14707","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MDR 2017\/745 Medical Devices Regulation: the major changes<\/title>\n<meta name=\"description\" content=\"The MDR 2017\/745 Medical Devices Regulation full application date was recently extended to May 26, 2021. We remember the most important MDR changes and 5 tips.\" \/>\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.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR 2017\/745 Medical Devices Regulation: the major changes\" \/>\n<meta property=\"og:description\" content=\"The MDR 2017\/745 Medical Devices Regulation full application date was recently extended to May 26, 2021. We remember the most important MDR changes and 5 tips.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema Med\" \/>\n<meta property=\"article:published_time\" content=\"2020-06-17T15:43:36+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/Regolamento-Dispositivi-Medici-mdr-2017-745-1024x535.png\" \/>\n<meta name=\"author\" content=\"redazione\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"redazione\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/\"},\"author\":{\"name\":\"redazione\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\"},\"headline\":\"MDR 2017\/745 Medical Devices Regulation: the major changes\",\"datePublished\":\"2020-06-17T15:43:36+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/\"},\"wordCount\":827,\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/Regolamento-Dispositivi-Medici-mdr-2017-745-1024x535.png\",\"articleSection\":[\"BLOG\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/\",\"url\":\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/\",\"name\":\"MDR 2017\/745 Medical Devices Regulation: the major changes\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/Regolamento-Dispositivi-Medici-mdr-2017-745-1024x535.png\",\"datePublished\":\"2020-06-17T15:43:36+00:00\",\"description\":\"The MDR 2017\/745 Medical Devices Regulation full application date was recently extended to May 26, 2021. We remember the most important MDR changes and 5 tips.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#primaryimage\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/Regolamento-Dispositivi-Medici-mdr-2017-745-1024x535.png\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/Regolamento-Dispositivi-Medici-mdr-2017-745-1024x535.png\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.thema-med.com\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"MDR 2017\/745 Medical Devices Regulation: the major changes\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#website\",\"url\":\"https:\/\/www.thema-med.com\/en\/\",\"name\":\"Thema Med\",\"description\":\"Quality and Regulatory Affairs for Medical Devices\",\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.thema-med.com\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":[\"Organization\",\"Place\"],\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\",\"name\":\"Thema\",\"alternateName\":\"Thema\",\"url\":\"https:\/\/www.thema-med.com\/en\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"width\":2440,\"height\":2851,\"caption\":\"Thema\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/\"],\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\",\"name\":\"redazione\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"caption\":\"redazione\"},\"sameAs\":[\"http:\/\/www.thema-med.eu\"],\"url\":\"https:\/\/www.thema-med.com\/en\/author\/emanuele\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"MDR 2017\/745 Medical Devices Regulation: the major changes","description":"The MDR 2017\/745 Medical Devices Regulation full application date was recently extended to May 26, 2021. We remember the most important MDR changes and 5 tips.","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.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/","og_locale":"en_US","og_type":"article","og_title":"MDR 2017\/745 Medical Devices Regulation: the major changes","og_description":"The MDR 2017\/745 Medical Devices Regulation full application date was recently extended to May 26, 2021. We remember the most important MDR changes and 5 tips.","og_url":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/","og_site_name":"Thema Med","article_published_time":"2020-06-17T15:43:36+00:00","og_image":[{"url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/Regolamento-Dispositivi-Medici-mdr-2017-745-1024x535.png","type":"","width":"","height":""}],"author":"redazione","twitter_card":"summary_large_image","twitter_misc":{"Written by":"redazione","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#article","isPartOf":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/"},"author":{"name":"redazione","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e"},"headline":"MDR 2017\/745 Medical Devices Regulation: the major changes","datePublished":"2020-06-17T15:43:36+00:00","mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/"},"wordCount":827,"publisher":{"@id":"https:\/\/www.thema-med.com\/en\/#organization"},"image":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#primaryimage"},"thumbnailUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/Regolamento-Dispositivi-Medici-mdr-2017-745-1024x535.png","articleSection":["BLOG"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/","url":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/","name":"MDR 2017\/745 Medical Devices Regulation: the major changes","isPartOf":{"@id":"https:\/\/www.thema-med.com\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#primaryimage"},"image":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#primaryimage"},"thumbnailUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/Regolamento-Dispositivi-Medici-mdr-2017-745-1024x535.png","datePublished":"2020-06-17T15:43:36+00:00","description":"The MDR 2017\/745 Medical Devices Regulation full application date was recently extended to May 26, 2021. We remember the most important MDR changes and 5 tips.","breadcrumb":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#primaryimage","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/Regolamento-Dispositivi-Medici-mdr-2017-745-1024x535.png","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/Regolamento-Dispositivi-Medici-mdr-2017-745-1024x535.png"},{"@type":"BreadcrumbList","@id":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.thema-med.com\/en\/"},{"@type":"ListItem","position":2,"name":"MDR 2017\/745 Medical Devices Regulation: the major changes"}]},{"@type":"WebSite","@id":"https:\/\/www.thema-med.com\/en\/#website","url":"https:\/\/www.thema-med.com\/en\/","name":"Thema Med","description":"Quality and Regulatory Affairs for Medical Devices","publisher":{"@id":"https:\/\/www.thema-med.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.thema-med.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":["Organization","Place"],"@id":"https:\/\/www.thema-med.com\/en\/#organization","name":"Thema","alternateName":"Thema","url":"https:\/\/www.thema-med.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","width":2440,"height":2851,"caption":"Thema"},"image":{"@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/"],"mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/06\/17\/mdr-2017-745-medical-devices-regulation-the-major-changes\/"}},{"@type":"Person","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e","name":"redazione","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","caption":"redazione"},"sameAs":["http:\/\/www.thema-med.eu"],"url":"https:\/\/www.thema-med.com\/en\/author\/emanuele\/"}]}},"_links":{"self":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/14707","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/comments?post=14707"}],"version-history":[{"count":0,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/14707\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/media?parent=14707"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/categories?post=14707"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/tags?post=14707"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}