{"id":10842,"date":"2024-01-23T15:22:54","date_gmt":"2024-01-23T21:22:54","guid":{"rendered":"https:\/\/casusconsulting.com\/?p=10842"},"modified":"2024-04-05T17:54:24","modified_gmt":"2024-04-05T22:54:24","slug":"new-eu-commission-proposal-delay-postpone-ivdr-2027-to-2029-eudamed-gradual-rollout","status":"publish","type":"post","link":"https:\/\/casusconsulting.com\/new-eu-commission-proposal-delay-postpone-ivdr-2027-to-2029-eudamed-gradual-rollout\/","title":{"rendered":"New Commission Proposal: Further Delay to IVDR, New Reporting Obligation &#038; New EUDAMED Deadline"},"content":{"rendered":"\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-10 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-a8e04b98-fe2b-42bd-9e7d-4fd19d0b85af\" 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-commission-proposal-delay-postpone-ivdr-2027-to-2029-eudamed-gradual-rollout\/#0-ivdr-postponement->IVDR Postponement<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/new-eu-commission-proposal-delay-postpone-ivdr-2027-to-2029-eudamed-gradual-rollout\/#4-new-reporting-obligation-for-manufacturers->New Reporting Obligation for Manufacturers<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/new-eu-commission-proposal-delay-postpone-ivdr-2027-to-2029-eudamed-gradual-rollout\/#5-eudamed-gradual-rollout->EUDAMED Gradual Rollout<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/new-eu-commission-proposal-delay-postpone-ivdr-2027-to-2029-eudamed-gradual-rollout\/#9-what%E2%80%99s-next-for-the-mdr-amp-ivdr->What\u2019s next for the MDR &amp; IVDR?<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/new-eu-commission-proposal-delay-postpone-ivdr-2027-to-2029-eudamed-gradual-rollout\/#10-further-reading->Further reading<\/a><\/li><\/ul><\/div><\/div><\/div>\n\n\n<div style=\"height:5px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The EU Commission issued a proposal to:<\/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>Further delay the IVDR, to give IVD companies more time to comply, <\/li>\n\n\n\n<li>Require manufacturers to report disruption to the supply of critical products, and<\/li>\n\n\n\n<li>Make some EUDAMED modules mandatory early, in a gradual rollout.<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:5px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The Proposal will be put forward to the European Parliament and Council for adoption. <\/p>\n\n\n\n<p>The announcement is available: <strong><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/commission-proposes-extend-transition-periods-certain-ivds-gradual-roll-out-eudamed-and-information-2024-01-23_en\" target=\"_blank\" rel=\"noreferrer noopener\">HERE<\/a><\/strong><\/p>\n\n\n\n<div style=\"height:10px\" 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-c39488a301d7d78b8a19955350860a8a\" id=\"0-ivdr-postponement-\"><strong><strong>IVDR Postponement<\/strong><\/strong><\/h2>\n\n\n\n<p>The Commission is concerned regarding the lack of Notified Body applications, especially for high-risk IVDs. The Commission notes that \u201cit is estimated that around 70% of clinical decisions are made using&nbsp;<em>in vitro<\/em>&nbsp;diagnostic medical devices.\u201d<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-52d05ebe6673416db732db2a60478e16\" id=\"1-proposed-new-compliance-dates-\"><strong>Proposed New Compliance Dates<\/strong><\/h3>\n\n\n\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: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>Class D &#8211; from 26 May 2025 to 31 December 2027<\/li>\n\n\n\n<li>Class C &#8211; from 26 May 2026 to 31 December 2028<\/li>\n\n\n\n<li>Class B &amp; Class A sterile &#8211; from 26 May 2027 to 31 December 2029<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p>Class A non-sterile devices already had to comply with the IVDR on its original date of application (26 May 2022).<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-15f8a761b75336a4d580e6b53b46c749\" id=\"2-which-devices-are-eligible-\"><strong>Which Devices are Eligible?<\/strong><\/h3>\n\n\n\n<p>This is not a postponement for new products. It is a postponement to <span class=\"tooltip tooltip-txt\" data-tooltip=\"Legacy devices are those that had valid CE marking under the MDD\/AIMDD\/IVDD and are allowed to continue to be placed on the EU market after the MDR\/IVDR went into force, due to the transition period allowance. Certain conditions apply, in order to remain a legacy device.\" data-position=\"top\">&#8216;legacy&#8217;<\/span>\n devices. IVDs new to the market must comply with the IVDR before being placed on the market.<\/p>\n\n\n\n<p>*For more information on this topic, please read: <strong><a href=\"https:\/\/casusconsulting.com\/what-are-legacy-devices\/\" target=\"_blank\" rel=\"noreferrer noopener\">Legacy Devices \u2013 Definition, Conditions, Deadlines<\/a><\/strong><\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-4f9793d5fd6d3c5a6fa663b71b313884\" id=\"3-additional-deadlines-to-qualify-for-extension-\"><strong><strong>Additional Deadlines<\/strong><\/strong> <strong>to Qualify for Extension <\/strong><\/h3>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-3 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>All manufacturers:\n<ul>\n<li>Implement an IVDR-compliant QMS (per IVDR Article 10(8)) by 26 May 2025<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-4 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>IVDs with IVDD Notified Body issued CE Certificates (Self-test, Annex II List A &amp; List B)<ul><li>Lodge an application with Notified Body by 26 May 2025<\/li><\/ul>\n<ul>\n<li>Have a signed agreement with Notified Body by 26 September 2025<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-5 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>Class D devices:<ul><li>Lodge an application with Notified Body by 26 May 2025<\/li><\/ul>\n<ul>\n<li>Have a signed agreement with Notified Body by 26 September 2025<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-6 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>Class C devices<ul><li>Lodge an application with Notified Body by 26 May 2026<\/li><\/ul>\n<ul>\n<li>Have a signed agreement with Notified Body by 26 September 2026<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-7 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>Class B &amp; Class A sterile devices<ul><li>Lodge an application with Notified Body by 26 May 2027<\/li><\/ul>\n<ul>\n<li>Have a signed agreement with Notified Body by 26 September 2027<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:10px\" 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-09af4c656f1157cda1064917e6b4abda\" id=\"4-new-reporting-obligation-for-manufacturers-\"><strong>New Reporting Obligation for Manufacturers<\/strong><\/h2>\n\n\n\n<p>A new section to Article 10 (General obligations of manufacturers) is being proposed. This will affect both the MDR and IVDR.<\/p>\n\n\n\n<p>This new section will require that manufacturers give at least six months&#8217; advance notice, if they expect an interruption to the supply of critical products. Notice must be given to the relevant competent authorities, health institutions or healthcare professionals, and economic operators (e.g., importers, distributors, procedure pack producers) to whom they directly supply the device.<\/p>\n\n\n\n<p>This requirement will apply to both MDR\/IVDR CE marked and legacy (MDD\/AIMDD\/IVDD) CE marked devices.<\/p>\n\n\n\n<p class=\"has-background\" style=\"background-color:#f8f8f8\">\u201cArticle 10(a) Obligations in case of interruption of supply of certain devices<\/p>\n\n\n\n<p class=\"has-background\" style=\"background-color:#f8f8f8\">(1) Where a manufacturer&nbsp;anticipates&nbsp;an interruption of&nbsp;the&nbsp;supply of a device, other than a custom-made device, and&nbsp;<em>where&nbsp;it is reasonably foreseeable&nbsp;that&nbsp;this interruption&nbsp;may&nbsp;result in&nbsp;serious harm or a risk of serious harm to patients or public health&nbsp;in one or more Member States<\/em>, the manufacturer shall inform the competent authority of the Member State where&nbsp;it&nbsp;or its authorised representative is established, as well as the economic operators, health institutions and healthcare professionals to whom&nbsp;the manufacturer&nbsp;directly supplies&nbsp;the device,&nbsp;of the&nbsp;anticipated&nbsp;interruption.<\/p>\n\n\n\n<p class=\"has-background\" style=\"background-color:#f8f8f8\">The information referred to in the first subparagraph shall, other than in exceptional circumstances, <em>be provided at least six months before the anticipated interruption<\/em>. The information provided to the competent authority shall specify the reasons for the interruption.<\/p>\n\n\n\n<p class=\"has-background\" style=\"background-color:#f8f8f8\">(2) The competent authority that has received the information referred to in paragraph 1 shall inform&nbsp;without undue delay&nbsp;the competent authorities of the&nbsp;other Member States and the Commission of the anticipated interruption.<\/p>\n\n\n\n<p class=\"has-background\" style=\"background-color:#f8f8f8\">(3) The economic operators&nbsp;who have received the information from the manufacturer&nbsp;in&nbsp;accordance with&nbsp;paragraph 1,&nbsp;shall&nbsp;inform&nbsp;without undue delay&nbsp;any other economic operators, health institutions and healthcare professionals to whom they directly supply&nbsp;the device&nbsp;of the anticipated interruption.\u2019\u201d<\/p>\n\n\n\n<div style=\"height:10px\" 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-80ad67b0b73f6cf5e6cb94c9d6d4398d\" id=\"5-eudamed-gradual-rollout-\"><strong><strong>EUDAMED Gradual Rollout<\/strong><\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-8d891456f64cfaa6b6584a1c035bdac3\" id=\"6-background-\"><strong>Background<\/strong><\/h3>\n\n\n\n<p>Current legislation stipulates EUDAMED will not be mandatory until all six modules are fully functional. At this time, only three of the six modules have been released (and are available for voluntary use).<\/p>\n\n\n\n<p>EUDAMED was originally scheduled to \u2018go-live\u2019 on the MDR\u2019s original date of application (26 May 2020). However, it has been beset with delays. It is now not expected to be fully functional until 2027, at the earliest.<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-bf24ac5216785e2cdfbc9941e03fd945\" id=\"7-the-update-\"><strong>The Update<\/strong><\/h3>\n\n\n\n<p>The Commission is proposing that EUDAMED modules become mandatory in a gradual roll-out, instead of requiring the entire system to be fully functional.<\/p>\n\n\n\n<p>Per the press release, some modules may become mandatory by late 2025. Presumably, this will include the modules related to <span class=\"tooltip tooltip-txt\" data-tooltip=\"Economic Operators are defined in the MDR\/IVDR as: manufacturers, system\/procedure pack producers, authorized representatives, importers, and distributors.\" data-position=\"top\">Economic Operator<\/span>\n and device registration.<\/p>\n\n\n\n<p>Both the MDR and IVDR would be amended for this change.<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color has-medium-font-size wp-elements-1f9476e38b452364129ae58397a2b8a0\" id=\"8-proposed-new-dates-\"><strong><strong>Proposed New Dates<\/strong><\/strong><\/h3>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8 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>Obligations and requirements shall apply 6-months after being published in the Official Journal of the European Union (OJEU)<\/li>\n\n\n\n<li>No later than 6 months after publication in the OJEU:\n<ul>\n<li>Manufacturers must register themselves and their devices in EUDAMED (Actor &amp; UDI\/Devices modules).<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>No later than 12 months after publication in the OJEU:\n<ul>\n<li>Notified Bodies shall enter information regarding certificates, e.g., issued, amendments, supplements, suspensions, reinstatements, withdrawals, refusals, and\/or restrictions.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>No later than 5 years after publication in the OJEU:<ul><li>All member states shall be required to use the clinical investigation\/performance evaluation module.<\/li><\/ul>\n<ul>\n<li>Before that date, and at least six months after publication in the OJEU, the clinical investigation\/performance evaluation module shall be applied only to the member states that have agreed to apply it.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p>The EUDAMED Actor and UDI\/Device registration modules will be applicable for both MDR\/IVDR and legacy (MDD\/AIMDD\/IVDD) devices.<\/p>\n\n\n\n<p>NOTE: In principle, all custom-made devices, except Class III implantable, are excluded from EUDAMED registration requirements. Instead, custom-made devices require registration with each national Competent Authority, on a case-by-case basis. However, in some situations, custom-made devices will still need to be registered in EUDAMED, e.g., in order to report a serious incident or to submit a trend report.<\/p>\n\n\n\n<div style=\"height:10px\" 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-9564ca37396e1c3b7e9e98412126cf2f\" id=\"9-what%E2%80%99s-next-for-the-mdr-amp-ivdr-\"><strong>What\u2019s next for the MDR &amp; IVDR?<\/strong><\/h2>\n\n\n\n<p>The Commission will be evaluating how the new legislation (MDR, IVDR) is impacting the availability of certain devices on the European market, such as innovative devices and pediatric devices. Further, it will assess the costs and administrative burdens of complying with the legislation; particularly, its impact on small-to-medium-sized manufacturers.<\/p>\n\n\n\n<div style=\"height:10px\" 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-6e0d1b90d52538514a7f0fc9cd1fa086\" id=\"10-further-reading-\"><strong><strong>Further reading<\/strong><\/strong><\/h2>\n\n\n\n<p>You may also be interested in the following:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9 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\/eudamed_basics\/\" target=\"_blank\" rel=\"noreferrer noopener\">EUDAMED: Overview<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/casusconsulting.com\/registering-your-company-in-eudamed\/\" target=\"_blank\" rel=\"noreferrer noopener\">EUDAMED: How to Register in the Actor Module<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/casusconsulting.com\/registering-devices-in-eudamed\/\" target=\"_blank\" rel=\"noreferrer noopener\">EUDAMED: How to Register in the UDI\/Devices Module<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/casusconsulting.com\/eu-registration-requirements\/\" target=\"_blank\" rel=\"noreferrer noopener\">Current Registration Requirements in Europe, UK, and Switzerland<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/casusconsulting.com\/mdr-ivdr-legacy-medical-device-2020-3-ivd-2022-6-mdcg-significant-change-guidance\/\" target=\"_blank\" rel=\"noreferrer noopener\">MDR\/IVDR Legacy Device Change Assessment Tool<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/casusconsulting.com\/services\/europe\/ivdr-ce-marking\/\" target=\"_blank\" rel=\"noreferrer noopener\">IVDR CE Marking Overview<\/a><\/strong><\/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\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>New Commission Proposal to 1) further the delay the IVDR for &#8216;legacy&#8217; devices 2) require manufacturers to report disruption to device supply, and 3) new EUDAMED &#8220;roll-out&#8221; deadlines. <\/p>\n","protected":false},"author":4,"featured_media":10864,"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":["1714079311:4"],"_tve_js_modules_gutenberg":["a:1:{i:0;s:9:\"gutenberg\";}"],"_edit_last":["4"],"_genesis_title":["Jan2024: IVDR Postponed Again, New EUDAMED Dates"],"_genesis_description":["New Commission Proposal to 1) further the delay the IVDR for \u2018legacy\u2019 devices 2) require manufacturers to report disruption to device supply, and 3) new EUDAMED \u201croll&#x2d;out\u201d deadlines."],"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":["Jan2024: IVDR Postponed Again, New EUDAMED Dates"],"mfn-meta-seo-description":["New Commission Proposal to 1) further the delay the IVDR for 'legacy' devices 2) require manufacturers to report disruption to device supply, and 3) new EUDAMED \"roll-out\" deadlines. 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