{"id":15833,"date":"2020-09-22T11:50:46","date_gmt":"2020-09-22T09:50:46","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=15833"},"modified":"2023-01-24T14:59:06","modified_gmt":"2023-01-24T13:59:06","slug":"eu-published-guidance-ifu-reusable-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/eu-published-guidance-ifu-reusable-devices\/","title":{"rendered":"EU: published guidance for Instructions For Use (IFU) for reusable devices"},"content":{"rendered":"\n<p>At the end of July 2020 the European Commission published a guide to address the issue of frequent <strong>non-compliance with instructions for use (IFU) for reusable and re-sterilizable medical devices<\/strong>.<\/p>\n\n\n\n<p>The guide has\nbeen drawn up by the <strong>Compliance and\nEnforcement Group (COEN)<\/strong>.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/09\/ce-istruzioni-dispositivi-medici-riutilizzabili-1024x536.png\" alt=\"Published guidance for Instructions For Use (IFU) for reusable devices\" class=\"wp-image-15728\"\/><figcaption>Published guidance for Instructions For Use (IFU) for reusable devices<\/figcaption><\/figure>\n\n\n\n<p>Essentially, the\ndocument presents <strong>two check-lists <\/strong>that\nthe Manufacturer must comply with in order to obtain a positive result in the conformity\nassessment of his reusable medical devices, before placing on the market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Check-list based on ISO 17664 and ISO 14937<\/strong><\/h2>\n\n\n\n<p>The first is a <strong>control check-list for IFU based partially on the EN ISO 17644 standard\n<\/strong>\u201cSterilization of medical devices \u2013\nInformation to be provided by the manufacturer for the processing of\nresterilisable medical devices\u201d.<\/p>\n\n\n\n<p>The second is a <strong>control check-list based on EN ISO 14937 <\/strong>for the assessment of the\nvalidation of the reconditioning of reusable medical devices, identified as: \u201cSterilization\nof health care products \u2013 General requirements for characterization of a\nsterilizing agent and the development, validation and routine control of a\nsterilization process for medical devices\u201d.<\/p>\n\n\n\n<p>Specifically, the control lists\nhighlight several important aspects, such as cleaning and disinfection\nprocesses, sterilization and storage methods of devices and criteria for\nevaluation.<\/p>\n\n\n\n<p>In conclusion, the two check-lists are\nuseful because they provide the Manufacturer and other parties involved with\nthe right tools to understand if their reusable medical devices are valid to be\nplaced on the market. <\/p>\n\n\n\n<p class=\"has-medium-font-size\"><strong>Do you need more information?<\/strong><\/p>\n\n\n\n<p><strong>Trust our\nThema consultants! <\/strong><\/p>\n\n\n\n<p>Thanks to their professionalism and expertise, our experts are able to provide you with a&nbsp;range&nbsp;of&nbsp;information&nbsp;about&nbsp;it. <\/p>\n\n\n\n<p>Discover all our services on <a href=\"https:\/\/www.thema-med.com\/en\/services\/\">www.thema-med.com<\/a> !<\/p>\n\n\n\n<p><a href=\"https:\/\/www.thema-med.com\/en\/newsletter\/\"><strong>Subscribe to our newsletter<\/strong><\/a> to stay updated on the latest news in the strategic-regulatory area and on Thema activities!<\/p>\n\n\n\n<p><a href=\"mailto:sales@thema-group.it\"><strong>Contact us<\/strong><\/a> and discover what we can do for you!<\/p>\n\n\n\n<p><em>Source:<\/em> <\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/md_sector\/docs\/md_checklists-iso-17664-14937_en.pdf\">https:\/\/ec.europa.eu\/health\/sites\/health\/files\/md_sector\/docs\/md_checklists-iso-17664-14937_en.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>At the end of July 2020 the European Commission published a guide to address the issue of frequent non-compliance with instructions  [&#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":[2],"tags":[],"class_list":["post-15833","post","type-post","status-publish","format-standard","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: published guidance for Instructions For Use (IFU) for reusable devices<\/title>\n<meta name=\"description\" content=\"Published a guide, has been drawn up by the Compliance and Enforcement Group (COEN), on instructions for use (IFU) of 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