{"id":9557,"date":"2021-06-04T14:20:33","date_gmt":"2021-06-04T12:20:33","guid":{"rendered":"https:\/\/riap.iss.it\/riap\/?p=9557"},"modified":"2021-06-04T14:21:56","modified_gmt":"2021-06-04T12:21:56","slug":"the-european-mdr-came-into-effect","status":"publish","type":"post","link":"https:\/\/riap.iss.it\/riap\/en\/news-and-events\/news\/2021\/06\/04\/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\" rel=\"nofollow\" target=\"_blank\">Medical Devices Regulation (EU) 2017\/745<\/a> (<strong><em>MDR<\/em><\/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\" rel=\"nofollow\" target=\"_blank\">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\" rel=\"nofollow\" target=\"_blank\">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\" rel=\"nofollow\" target=\"_blank\">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\" rel=\"nofollow\" target=\"_blank\">Information on Unique Device Identifier<\/a><\/li>\n<\/ul>\n<p>The new Regulation is fully effective for the joint prostheses considered by the Riap.<\/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 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 &hellip;<\/p>\n","protected":false},"author":5,"featured_media":9555,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[116],"tags":[],"class_list":["post-9557","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/riap.iss.it\/riap\/wp-json\/wp\/v2\/posts\/9557","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/riap.iss.it\/riap\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/riap.iss.it\/riap\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/riap.iss.it\/riap\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/riap.iss.it\/riap\/wp-json\/wp\/v2\/comments?post=9557"}],"version-history":[{"count":0,"href":"https:\/\/riap.iss.it\/riap\/wp-json\/wp\/v2\/posts\/9557\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/riap.iss.it\/riap\/wp-json\/wp\/v2\/media\/9555"}],"wp:attachment":[{"href":"https:\/\/riap.iss.it\/riap\/wp-json\/wp\/v2\/media?parent=9557"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/riap.iss.it\/riap\/wp-json\/wp\/v2\/categories?post=9557"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/riap.iss.it\/riap\/wp-json\/wp\/v2\/tags?post=9557"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}