{"id":3684,"date":"2025-05-30T12:30:27","date_gmt":"2025-05-30T12:30:27","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3684"},"modified":"2025-07-18T09:58:32","modified_gmt":"2025-07-18T09:58:32","slug":"sterile-gloves-sterile-devices-and-patient-transport-equipment-what-changed-in-2025","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/sterile-gloves-sterile-devices-and-patient-transport-equipment-what-changed-in-2025\/","title":{"rendered":"Sterile gloves, sterile devices and patient transport equipment: what changed in 2025"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>In 2025, the European Commission introduced a new set of <b>harmonised standards<\/b> under the MDR (EU) 2017\/745 and IVDR (EU) 2017\/746 frameworks. These updates directly affect MDR technical documentation required for compliance and market access.<\/p>\n<p>If you manufacture <b>single-use medical gloves, sterile-labelled medical devices, or patient transport equipment<\/b>, you may need to update your technical documentation and conformity assessment procedures.<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/sterile-gloves-sterile-devices-and-patient-transport-equipment-what-changed-in-2025\/#New_harmonised_standards_published_in_2025\" >New harmonised standards published in 2025<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/sterile-gloves-sterile-devices-and-patient-transport-equipment-what-changed-in-2025\/#Why_you_must_update_your_MDR_technical_documentation\" >Why you must update your MDR technical documentation<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/sterile-gloves-sterile-devices-and-patient-transport-equipment-what-changed-in-2025\/#Compliance_and_MDR_documentation_updates_for_manufacturers\" >Compliance and MDR documentation updates for manufacturers<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"New_harmonised_standards_published_in_2025\"><\/span>New harmonised standards published in 2025<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>Implementing Decision (EU) 2025\/681 harmonised the following standards under MDR:<\/b><\/p>\n<ul>\n<li><strong>EN 455-1:2020+A2:2024<\/strong> \u2013 Medical gloves for single use. Requirements and testing for freedom of holes<\/li>\n<li><strong>EN 455-2:2024<\/strong> \u2013 Medical gloves for single use &#8211; Part 2: Requirements and testing for physical properties<\/li>\n<li><strong>EN 556-1:2024<\/strong> \u2013 Sterilization of medical devices. Requirements for medical devices to be designated \u00abSTERILE\u00bb. Requirements for terminally sterilized medical devices<\/li>\n<li><strong>EN 556-2:2024<\/strong> \u2013 Sterilization of medical devices &#8211; Requirements for medical devices to be designated \u00abSTERILE\u00bb &#8211; Part 2: Requirements for aseptically processed medical devices<\/li>\n<li><strong>EN 1865-2:2024<\/strong> \u2013 Patient handling equipment used in ambulances &#8211; Part 2: Power assisted stretcher<\/li>\n<li><strong>EN 1865-6:2024<\/strong> \u2013 Patient handling equipment used in ambulances &#8211; Part 6: Powered chairs<\/li>\n<\/ul>\n<p><b>For IVDs, Implementing Decision (EU) 2025\/679 includes:<\/b><\/p>\n<ul>\n<li><strong>EN 556-1:2024<\/strong> \u2013 Sterilization of medical devices. Requirements for medical devices to be designated \u00abSTERILE\u00bb. Requirements for terminally sterilized medical devices<\/li>\n<li><strong>EN 556-2:2024<\/strong> \u2013 Sterilization of medical devices &#8211; Requirements for medical devices to be designated \u00abSTERILE\u00bb &#8211; Part 2: Requirements for aseptically processed medical devices<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Why_you_must_update_your_MDR_technical_documentation\"><\/span>Why you must update your MDR technical documentation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>These <b>harmonised standards 2025<\/b> aim to strengthen <b>medical device conformity<\/b> across the EU market. However, manufacturers must take action to maintain <b>MDR compliance<\/b>.<\/p>\n<p>You should revise your <b>MDR technical documentation<\/b> to:<\/p>\n<ul>\n<li><span style=\"background-color: rgba(0, 0, 0, 0);\">Reference the correct versions of the newly harmonised standards<\/span><\/li>\n<li><span style=\"background-color: rgba(0, 0, 0, 0);\">Verify that performance and safety requirements are still fulfilled<\/span><\/li>\n<li><span style=\"background-color: rgba(0, 0, 0, 0);\">Update risk assessments and clinical evaluations accordingly<\/span><\/li>\n<\/ul>\n<div>\n<h2><span class=\"ez-toc-section\" id=\"Compliance_and_MDR_documentation_updates_for_manufacturers\"><\/span>Compliance and MDR documentation updates for manufacturers<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>To comply with MDR and IVDR, you should:<\/b><\/p>\n<ul>\n<li>\n<p style=\"background-color: rgba(0, 0, 0, 0); display: inline !important;\">Review your existing technical documentation for all affected product categories<\/p>\n<\/li>\n<li>Update labelling, instructions for use, and sterilisation validations where needed<\/li>\n<li>Make sure all test reports rely on the most current harmonised standards<\/li>\n<\/ul>\n<p><b>Not sure if your device complies with the 2025 harmonised standards?<\/b><\/p>\n<p><b>We support manufacturers in updating MDR technical documentation and applying <a href=\"https:\/\/cmcmedicaldevices.com\/services\/consulting-mdr\/\" target=\"_blank\" rel=\"noopener noreferrer\"><u>MDR<\/u><\/a> and <a href=\"https:\/\/cmcmedicaldevices.com\/services\/consulting-ivdr\/\" target=\"_blank\" rel=\"noopener noreferrer\"><u>IVDR<\/u><\/a> requirements correctly.<\/b><\/p>\n<\/div>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_margin-top:10px;--button_margin-bottom:20px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us today<\/span><\/a><\/div><div class=\"fusion-image-element \" style=\"text-align:center;--awb-max-width:600px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1640\" height=\"924\" alt=\"new standards gloves and sterile medical devices\" title=\"new standards gloves and sterile medical devices\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/new-standar-gloves-and-sterile-medical-devices.jpg\" class=\"img-responsive wp-image-3687\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/new-standar-gloves-and-sterile-medical-devices-200x113.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/new-standar-gloves-and-sterile-medical-devices-400x225.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/new-standar-gloves-and-sterile-medical-devices-600x338.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/new-standar-gloves-and-sterile-medical-devices-800x451.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/new-standar-gloves-and-sterile-medical-devices-1200x676.jpg 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/new-standar-gloves-and-sterile-medical-devices.jpg 1640w\" sizes=\"(max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/div>\n\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-center kksr-valign-bottom\"\n    data-payload='{&quot;align&quot;:&quot;center&quot;,&quot;id&quot;:&quot;3684&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;bottom&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;3&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;5&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;Rate this&quot;,&quot;legend&quot;:&quot;5\\\/5 - (3 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;Sterile gloves, sterile devices and patient transport equipment: what changed in 2025&quot;,&quot;width&quot;:&quot;142.5&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 142.5px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            5\/5 - (3 votos)    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3684","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar","post_format-post-format-gallery"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>2025 Updates for gloves, sterile devices, transport equipment<\/title>\n<meta name=\"description\" content=\"MDR 2025: new standards for gloves, sterile devices, and transport equipment. Is your technical documentation still compliant?\" \/>\n<meta name=\"robots\" content=\"noindex, follow\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"2025 Updates for gloves, sterile devices, transport equipment\" \/>\n<meta property=\"og:description\" content=\"MDR 2025: new standards for gloves, sterile devices, and transport equipment. 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