{"id":27884,"date":"2023-05-30T16:09:53","date_gmt":"2023-05-30T14:09:53","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=27884"},"modified":"2023-08-04T12:18:17","modified_gmt":"2023-08-04T10:18:17","slug":"mdr-extension-main-dates-and-fulfilments","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2023\/05\/30\/mdr-extension-main-dates-and-fulfilments\/","title":{"rendered":"MDR Extension: main dates and fulfilments"},"content":{"rendered":"<p style=\"text-align: right;\">30 May 2023<\/p>\n<h3 class=\"_04xlpA direction-ltr align-start para-style-body\"><span class=\"WdYUQQ\">General conditions the extension of the transition period<\/span><\/h3>\n<ul>\n<li><span class=\"WdYUQQ\">Compliance with Directive <\/span><strong><span class=\"WdYUQQ\">90\/385\/EEC<\/span><\/strong><span class=\"WdYUQQ\"> or Directive<\/span><strong><span class=\"WdYUQQ\"> 93\/42\/EEC<\/span><\/strong><span class=\"WdYUQQ\">.<\/span><\/li>\n<li><span class=\"WdYUQQ\">No <\/span><strong><span class=\"WdYUQQ\">significant changes<\/span><\/strong><span class=\"WdYUQQ\"> in terms of design and intended use.<\/span><\/li>\n<li><span class=\"WdYUQQ\">No unacceptable risk to the health or safety of patients, users or third parties.<\/span><\/li>\n<li><strong><span class=\"WdYUQQ\">26 May 2024<\/span><\/strong><span class=\"WdYUQQ\">: implementation of a quality management system.<\/span><\/li>\n<li><strong><span class=\"WdYUQQ\">26 May 2024<\/span><\/strong><span class=\"WdYUQQ\">: application for certification.<\/span><\/li>\n<li><strong><span class=\"WdYUQQ\">26 September 2024<\/span><\/strong><span class=\"WdYUQQ\">: Notified Body and Manufacturer have signed agreement.<\/span><\/li>\n<\/ul>\n<h3><span class=\"WdYUQQ\">Devices with certificate or declaration of conformity issued before 26 May 2021<\/span><\/h3>\n<ul>\n<li><strong><span class=\"WdYUQQ\">31 December 2027<\/span><\/strong><span class=\"WdYUQQ\">: high risk devices, i.e. Class III and Class IIb implantable devices, with exceptions.<\/span><\/li>\n<li><strong><span class=\"WdYUQQ\">31 December 2028<\/span><\/strong><span class=\"WdYUQQ\">: medium and low risk devices, i.e. Class IIb, Class IIa and Im, Is and Ir.<\/span><\/li>\n<li><strong><span class=\"WdYUQQ\">26 May 2026<\/span><\/strong><span class=\"WdYUQQ\">: custom Class III implantable devices.<\/span><\/li>\n<\/ul>\n<h3><span class=\"WdYUQQ\">Medical devices with certificate or declaration of conformity expired before 20 March 2023<\/span><\/h3>\n<ul>\n<li><span class=\"WdYUQQ\">Signature of the agreement between Manufacturer and Notified Body for MDR certification.<\/span><\/li>\n<li><span class=\"WdYUQQ\">Granting of an exemption by the Competent Authority to the Manufacturer.<\/span><\/li>\n<\/ul>\n<p><img decoding=\"async\" class=\"wp-image-27895 alignleft\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/05\/Riferimento_regolamento-e1685453009849-1024x68.jpg\" alt=\"\" width=\"753\" height=\"50\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/05\/Riferimento_regolamento-e1685453009849-200x13.jpg 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/05\/Riferimento_regolamento-e1685453009849-300x20.jpg 300w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/05\/Riferimento_regolamento-e1685453009849-400x27.jpg 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/05\/Riferimento_regolamento-e1685453009849-600x40.jpg 600w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/05\/Riferimento_regolamento-e1685453009849-768x51.jpg 768w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/05\/Riferimento_regolamento-e1685453009849-800x53.jpg 800w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/05\/Riferimento_regolamento-e1685453009849-1024x68.jpg 1024w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/05\/Riferimento_regolamento-e1685453009849-1200x80.jpg 1200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/05\/Riferimento_regolamento-e1685453009849-1536x102.jpg 1536w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/05\/Riferimento_regolamento-e1685453009849.jpg 1862w\" sizes=\"(max-width: 753px) 100vw, 753px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>30 May 2023 General conditions the extension of the transition period Compliance with Directive 90\/385\/EEC or Directive 93\/42\/EEC. No significant changes  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":27886,"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":[679],"tags":[],"class_list":["post-27884","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MDR Extension: main dates and fulfilments - Thema Med<\/title>\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\/2023\/05\/30\/mdr-extension-main-dates-and-fulfilments\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR Extension: main dates and fulfilments - Thema Med\" \/>\n<meta property=\"og:description\" content=\"30 May 2023 General conditions the extension of the transition period Compliance with Directive 90\/385\/EEC or Directive 93\/42\/EEC. 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