{"id":18652,"date":"2021-07-22T09:13:40","date_gmt":"2021-07-22T07:13:40","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=18652"},"modified":"2023-01-25T17:19:07","modified_gmt":"2023-01-25T16:19:07","slug":"eu-amendment-of-mdr-eu-2017-745-oj-l241-7-08-07-2021","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/07\/22\/eu-amendment-of-mdr-eu-2017-745-oj-l241-7-08-07-2021\/","title":{"rendered":"EU: amendment of MDR (EU) 2017\/745|OJ L241\/7 08\/07\/2021"},"content":{"rendered":"\r\n<p>On 8 July 2021 an <strong>amendment to the Regulation on Medical Devices MDR<\/strong> <strong>(EU) 2017\/745<\/strong> was published in the Official Journal of the European Union (OJ L241\/7), highlighting some changes to correct, among other things, misprints, typos and translation errors.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-18608\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/07\/rettifica-mdr-ue-2017-745-dispositivi-medici-1024x536.jpg\" alt=\"Amendment of MDR (EU) 2017\/745|OJ L241\/7 08\/07\/2021\" \/>\r\n<figcaption>Amendment of MDR (EU) 2017\/745|OJ L241\/7 08\/07\/2021<\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>What are the most significant changes?<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>Among the amendments included in the Amending Document, the most significant are:<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>On page 104, attachment I, Chapter III, point 23.2, letters (c) and (d) <strong>General safety and performance requirements<\/strong>, the word <strong>\u201clegally\u201d <\/strong>has been added to registered office, as shown in the table below.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<table class=\"wp-block-table\">\r\n<tbody>\r\n<tr>\r\n<td><strong><em>instead of<\/em><\/strong><\/td>\r\n<td><strong><em>should be read as<\/em><\/strong><\/td>\r\n<\/tr>\r\n<tr>\r\n<td>\u201c (c) the name, trade name or registered trade mark of the manufacturer and the address of its <strong>registered office<\/strong>;\u201d<\/td>\r\n<td>\u201c (c) the name, trade name or registered trade mark of the manufacturer and the address of its <strong>legally<\/strong> <strong>registered office<\/strong>;\u201d<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>\u201c (d) if the manufacturer has its <strong>registered office <\/strong>outside the Union, the name of the authorised representative and the address of their legally registered office;\u201d<\/td>\r\n<td>\u201c (d) if the manufacturer has its<strong> legally registered office<\/strong> outside the Union, the name of the authorised representative and the address of their legally registered office;\u201d<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>At page 143, attachment VIII, Chapter III, point 5.4 (Rule 8), fourth indent<strong> Classification Rules<\/strong> the risk class has been changed: <strong>Implantable Medical Devices<\/strong> undergoing post-implantation modifications from <strong>Class IIb<\/strong> to <strong>Class III<\/strong>, as shown in the following table.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<table class=\"wp-block-table\">\r\n<tbody>\r\n<tr>\r\n<td><strong><em>instead of<\/em><\/strong><\/td>\r\n<td><strong><em>should be read as<\/em><\/strong><\/td>\r\n<\/tr>\r\n<tr>\r\n<td>\u201c\u2013 are intended to undergo a chemical modification after introduction into the body, in which case they belong to <strong>Class IIb<\/strong>, except when placed in the teeth,\u201d<\/td>\r\n<td>\u201c\u2013 are intended to undergo a chemical modification after introduction into the body, in which case they belong to <strong>Class III<\/strong>, except when placed in the teeth,\u201d<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n\r\n\r\n\r\n<p>For more details and to know all the changes made to the MDR (EU) 2017\/745 please consult the document published at the following link: <a href=\"https:\/\/bit.ly\/2UdWKHn\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">https:\/\/bit.ly\/2UdWKHn<\/a><\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Trust Thema to help you comply with the MDR (EU) 2017\/745 Regulation!<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>There are many tasks to be completed and requirements to be met in order to comply with the Medical Devices Regulation MDR (EU) 2017\/745.<\/p>\r\n\r\n\r\n\r\n<p>Don\u2019t waste any more time!<\/p>\r\n\r\n\r\n\r\n<p><a href=\"mailto:sales@thema-med.com\"><strong>Contact us<\/strong><\/a> to\u00a0 request valuable <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">strategic regulatory consulting<\/a><\/strong>.<\/p>\r\n\r\n\r\n\r\n<p><em>Source:<\/em><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/IT\/TXT\/PDF\/?uri=CELEX:32017R0745R(03)&amp;from=IT\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Official Journal of the European Union, OJ L 241\/7 08.07.2021 <\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>On 8 July 2021 an amendment to the Regulation on Medical Devices MDR (EU) 2017\/745 was published in the Official Journal  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23047,"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":[2],"tags":[],"class_list":["post-18652","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU: amendment of MDR (EU) 2017\/745|OJ L241\/7 08\/07\/2021<\/title>\n<meta name=\"description\" content=\"On 8 July 2021 an amendment to the Regulation on Medical Devices MDR (EU) 2017\/745 was published in the Official Journal of the European Union (OJ L241\/7).\" \/>\n<meta name=\"robots\" content=\"index, follow, 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