{"id":3117,"date":"2021-06-04T14:13:29","date_gmt":"2021-06-04T12:13:29","guid":{"rendered":"https:\/\/ripi.iss.it\/ripi\/?p=3117"},"modified":"2021-06-21T12:32:52","modified_gmt":"2021-06-21T10:32:52","slug":"the-european-mdr-came-into-effect","status":"publish","type":"post","link":"https:\/\/ripi.iss.it\/ripi\/en\/news\/article\/the-european-mdr-came-into-effect\/","title":{"rendered":"The European Medical Devices Regulation came into effect"},"content":{"rendered":"<p>On the 26<sup>th<\/sup> of May 2021, the new <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32017R0745\">Medical Devices Regulation (EU) 2017\/745<\/a> (<strong>MDR<\/strong>) came into effect. Medical devices placed on the EU market must now comply with the MDR. After the transitional period and a delay due to the COVID-19 emergency, this is an important date for manufacturers and their authorized representatives, as well as importers and distributors of medical devices.<\/p>\n<p>The full MDR text is available <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/2017-05-05\">here<\/a>.<\/p>\n<p>The European Commission provides more details:<\/p>\n<ul>\n<li><a href=\"https:\/\/ec.europa.eu\/health\/md_sector\/overview_en\">An overview of the regulatory framework for medical devices<\/a><\/li>\n<li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_newregulations\/docs\/importersdistributors_factsheet_en.pdf\">Factsheet for Authorised Representatives, Importers and Distributors of medical devices and in vitro diagnostic medical devices<\/a><\/li>\n<li><a href=\"https:\/\/ec.europa.eu\/health\/md_topics-interest\/unique_device_identifier_en\">Information on Unique Device Identifier<\/a><\/li>\n<\/ul>\n<p>The new Regulation is fully effective for the devices considered by the registries that make part of RIPI: joint prostheses, spinal implants, pacemakers, defibrillators, and heart valves.<\/p>\n<p id=\"tw-target-text\" class=\"tw-data-text tw-text-large XcVN5d tw-ta\" dir=\"ltr\" data-placeholder=\"Traduzione\"><span class=\"Y2IQFc\" lang=\"en\">For further information, see the article &#8220;<a href=\"https:\/\/ripi.iss.it\/ripi\/it\/news\/pubblicazioni\/regulation-for-the-italian-national-registry-of-implantable-prostheses\/\" target=\"_blank\" rel=\"noopener\">A far-reaching Regulation for the Italian National Registry of Implantable Prostheses: a possible model for other health registries<\/a>&#8221; by\u00a0 Virgilia Toccaceli and Marina Torre, recently published in the <em>Annali dell&#8217;Istituto Superiore di Sanit\u00e0<\/em>.<br \/>\n<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On the 26th of May 2021, the new Medical Devices Regulation (EU) 2017\/745 (MDR) came into effect. Medical devices placed on the EU market must &#8230; <\/p>\n","protected":false},"author":2,"featured_media":3115,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-3117","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-article"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>The European Medical Devices Regulation came into effect | RIPI<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/ripi.iss.it\/ripi\/en\/news\/article\/the-european-mdr-came-into-effect\/\" \/>\r\n<meta property=\"og:locale\" content=\"it_IT\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"The European Medical Devices Regulation came into effect | RIPI\" \/>\r\n<meta property=\"og:description\" content=\"On the 26th of May 2021, the new Medical Devices Regulation (EU) 2017\/745 (MDR) came into effect. 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