{"id":11464,"date":"2024-03-11T16:08:23","date_gmt":"2024-03-11T21:08:23","guid":{"rendered":"https:\/\/casusconsulting.com\/?p=11464"},"modified":"2024-04-05T17:50:12","modified_gmt":"2024-04-05T22:50:12","slug":"new-eu-mdr-ivdr-harmonized-standards-published","status":"publish","type":"post","link":"https:\/\/casusconsulting.com\/new-eu-mdr-ivdr-harmonized-standards-published\/","title":{"rendered":"New EU MDR\/IVDR Harmonized Standards Published"},"content":{"rendered":"\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-2 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:5%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:85%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><p><\/p><script src=\"https:\/\/9931674141ca41baa2023404fd2333a2.js.ubembed.com\" async=\"\"><\/script><\/p>\n\n\n<div class=\"wp-block-ub-table-of-contents-block ub_table-of-contents\" data-showtext=\"show\" data-hidetext=\"hide\" data-scrolltype=\"auto\" id=\"ub_table-of-contents-066cb598-f8a5-4186-9c25-4b609bf379fd\" data-initiallyhideonmobile=\"false\"\n                    data-initiallyshow=\"true\"><div class=\"ub_table-of-contents-header-container\"><div class=\"ub_table-of-contents-header\">\n                    <div class=\"ub_table-of-contents-title\">Table of Contents<\/div><\/div><\/div><div class=\"ub_table-of-contents-extra-container\"><div class=\"ub_table-of-contents-container ub_table-of-contents-1-column \"><ul><li><a href=https:\/\/casusconsulting.com\/new-eu-mdr-ivdr-harmonized-standards-published\/#0-overview>Overview<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/new-eu-mdr-ivdr-harmonized-standards-published\/#1-list-standards-newly-harmonized-under-the-mdr->List &#8211; Standards newly harmonized under the MDR<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/new-eu-mdr-ivdr-harmonized-standards-published\/#2-list-standards-newly-harmonized-under-the-ivdr->List &#8211; Standards newly harmonized under the IVDR<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/new-eu-mdr-ivdr-harmonized-standards-published\/#3-further-reading->Further Reading<\/a><\/li><\/ul><\/div><\/div><\/div>\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-a60c4eac583992f14f6255cec6285c8f\" id=\"0-overview\">Overview<\/h2>\n\n\n\n<p>MDR: Eight standards have been newly harmonized. These fall under Commission Implementing Decision (EU) 2024\/815. The link is available: <strong><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2024\/815\/oj\" target=\"_blank\" rel=\"noreferrer noopener\">HERE<\/a><\/strong><\/p>\n\n\n\n<p>IVDR: Three standards have been newly harmonized. These fall under Commission Implementing Decision (EU) 2024\/817. The link is available: <strong><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2024\/817\/oj\" target=\"_blank\" rel=\"noreferrer noopener\">HERE<\/a><\/strong><\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-a1cac9221c5be6c7634921a605962d39\" id=\"1-list-standards-newly-harmonized-under-the-mdr-\"><strong>List &#8211; Standards newly harmonized under the MDR<\/strong><\/h2>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>Reference number of the standard<\/strong><\/th><th><strong>Title of the standard<\/strong><\/th><\/tr><\/thead><tbody><tr><td>EN 455-3:2023<\/td><td>Medical gloves for single use \u2013 Part 3: Requirements and testing for biological evaluation<\/td><\/tr><tr><td>EN ISO 10993-15:2023<\/td><td>Biological evaluation of medical devices \u2013 Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)<\/td><\/tr><tr><td>EN ISO 10993-17:2023<\/td><td>Biological evaluation of medical devices \u2013 Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)<\/td><\/tr><tr><td>EN ISO 10993-18:2020 EN ISO 10993-18:2020\/A1:2023<\/td><td>Biological evaluation of medical devices \u2013 Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)<\/td><\/tr><tr><td>EN ISO 11137-2:2015 EN ISO 11137-2:2015\/A1:2023<\/td><td>Sterilization of health care products \u2013 Radiation \u2013 Part 2: Establishing the sterilization dose (ISO 11137-2:2013)<\/td><\/tr><tr><td>EN ISO 11607-1:2020 EN ISO 11607-1:2020\/A1:2023<\/td><td>Packaging for terminally sterilized medical devices \u2013 Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)<\/td><\/tr><tr><td>EN ISO 11607-2:2020 EN ISO 11607-2:2020\/A1:2023<\/td><td>Packaging for terminally sterilized medical devices \u2013 Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)<\/td><\/tr><tr><td>EN ISO 17664-2:2023<\/td><td>Processing of health care products \u2013 Information to be provided by the medical device manufacturer for the processing of medical devices \u2013 Part 2: Non-critical medical devices (ISO 17664-2:2021)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-3bc0e18b1f8ab4db21f3aeb510e14b19\" id=\"2-list-standards-newly-harmonized-under-the-ivdr-\"><strong>List &#8211; Standards newly harmonized under the IVDR<\/strong><\/h2>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>Reference number of the standard<\/strong><\/th><th><strong>Title of the standard<\/strong><\/th><\/tr><\/thead><tbody><tr><td>EN ISO 11137-2:2015 EN ISO 11137-2:2015\/A1:2023<\/td><td>Sterilization of health care products \u2013 Radiation \u2013 Part 2: Establishing the sterilization dose (ISO 11137-2:2013)<\/td><\/tr><tr><td>EN ISO 11607-1:2020 EN ISO 11607-1:2020\/A1:2023<\/td><td>Packaging for terminally sterilized medical devices \u2013 Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)<\/td><\/tr><tr><td>EN ISO 11607-2:2020 EN ISO 11607-2:2020\/A1:2023<\/td><td>Packaging for terminally sterilized medical devices \u2013 Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-055f28bc65e3af7c227bfb08b1fbf6be\" id=\"3-further-reading-\"><strong>Further Reading<\/strong><\/h2>\n\n\n\n<p>You may also be interested in the following topics:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul>\n<li><strong><a href=\"https:\/\/casusconsulting.com\/list-mdr-ivdr-harmonized-standards-common-specifications\/\" target=\"_blank\" rel=\"noreferrer noopener\">Full List of Harmonized Standards and Common Specifications<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/casusconsulting.com\/eu-importer-requirements-article-13-the-mdr-ivdr\/\" target=\"_blank\" rel=\"noreferrer noopener\">Importer Requirements under the MDR\/IVDR<\/a><\/strong><\/li>\n\n\n\n<li><a href=\"https:\/\/casusconsulting.com\/systems-procedure-packs-and-kits-requirements\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Systems\/Procedure Packs and Kits in the EU, UK, and Switzerland<\/strong><\/a> <\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Eight new standards have been harmonized under the EU MDR and three newly harmonized under the EU IVDR. Click here for the full list and links.<\/p>\n","protected":false},"author":4,"featured_media":11465,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ub_ctt_via":"","footnotes":""},"categories":[6],"tags":[12,8],"cp_meta_data":{"_edit_lock":["1712357413:4"],"_thumbnail_id":["11465"],"_edit_last":["4"],"_genesis_title":["March 2024: New MDR\/IVDR Harmonized Standards"],"_genesis_description":["Eight new standards have been harmonized under the EU MDR and three newly harmonized under the EU IVDR. Click here for the full list and links."],"hefo_before":["0"],"hefo_after":["0"],"cmplz_hide_cookiebanner":[""],"mfn-post-hide-content":["0"],"mfn-post-layout":["no-sidebar"],"mfn-post-sidebar":["0"],"mfn-post-sidebar2":["0"],"mfn-post-template":["intro"],"mfn-post-slider":["0"],"mfn-post-slider-layer":["0"],"mfn-post-full-width":["0"],"mfn-post-hide-title":["0"],"mfn-post-remove-padding":["0"],"mfn-post-intro":["a:1:{s:9:\"post-meta\";s:1:\"1\";}"],"mfn-meta-seo-title":["March 2024: New MDR\/IVDR Harmonized Standards"],"mfn-meta-seo-description":["Eight new standards have been harmonized under the EU MDR and three newly harmonized under the EU IVDR. 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