{"id":26430,"date":"2023-01-19T16:34:19","date_gmt":"2023-01-19T15:34:19","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=26430"},"modified":"2023-01-20T11:08:29","modified_gmt":"2023-01-20T10:08:29","slug":"europe-mdr-transition-period-extension-proposed-and-latest-mdcgs","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2023\/01\/19\/europe-mdr-transition-period-extension-proposed-and-latest-mdcgs\/","title":{"rendered":"EUROPE: MDR transition period extension proposed and latest MDCGs"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container 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:1144px;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:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>On 6<sup>th<\/sup> January, the European Commission issued a proposal to <strong>extend the transitional period<\/strong> under Art. 120 for MDR <strong>until 2027-2028<\/strong>: the extension would be necessary to give Manufacturers more time to switch from the previously applicable provisions to the new certification requirements for Medical Devices, as laid down in the <em>Medical Device Regulation<\/em>.<\/h2>\n<p>The overall objective of the extension is to ensure continued access for patients to a wide range of devices, while ensuring the transition to the new regulatory framework and allowing Medical Devices placed on the market, and still available, to remain on the market.<\/p>\n<p>Only devices for which Manufacturers have already taken steps to transition to MDR can benefit from the extension: in particular, the <strong>new deadlines<\/strong> depend on the <strong>type <\/strong>and<strong> risk class<\/strong> of Medical Devices. Specifically:<\/p>\n<ul>\n<li>Devices with a CE certificate or a declaration of conformity issued before 26<sup>th<\/sup> May 2021, including:\n<ul>\n<li>high risk, <strong>class III and class IIb implantable<\/strong> <strong>devices<\/strong> &gt; for these devices the transitional period is extended from 26<sup>th<\/sup> May 2024 until 31<sup>st<\/sup> December 2027;<\/li>\n<li>medium and low risk, <strong>class IIb devices and class IIa, Im, Is and Ir devices<\/strong> &gt; for these devices the transition period runs until 31<sup>st<\/sup> December 2028;<\/li>\n<li><strong>custom-made<\/strong> implantable class III devices with a request for conformity assessment by the manufacturer before 26<sup>th<\/sup> May 2024 &gt; transition period extended until 26<sup>th<\/sup> May 2026.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>The application of the extended transition period is subject to several conditions that must occur simultaneously, in particular:<\/p>\n<ul>\n<li>compliance with Directive 90\/385\/EEC or Directive 93\/42\/EEC, as applicable, must be maintained.<\/li>\n<li>the device must not be subject to significant change in terms of design and intended use.<\/li>\n<li>devices must not present an unacceptable risk to the health or safety of patients, users or third parties.<\/li>\n<li>by 26<sup>th<\/sup> May 2024, the manufacturer has implemented a MDR-compliant quality management system.<\/li>\n<li>by 26<sup>th<\/sup> May 2024, the manufacturer, or its Authorised Representative, has submitted an application for MDR certification, and by 26<sup>th<\/sup> September 2024, the Notified Body and the Manufacturer have signed a written proposal\/agreement.<\/li>\n<\/ul>\n<p>The proposal must now be discussed for approval and co-decision by the European Parliament and the Council.<\/p>\n<p>As far as the European regulatory framework is concerned, <strong>four new MDCG guidelines<\/strong> were recently published, in detail:<\/p>\n<p>&#8211; <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-12\/mdcg_2022-17_en_0.pdf\"><strong>MDCG 2022-17<\/strong><\/a> (6<sup>th<\/sup> December 2022), a guideline on <strong>hybrid audits<\/strong> (in-person and remotely): it defines some operational aspects on the duration and how to carry out &#8216;on-site&#8217; and &#8216;off-site&#8217; audits, on Manufacturers&#8217; quality management systems, in the context of first certification and surveillance processes, as set out in Regulations (EU) 2017\/745 and 2017\/746.<\/p>\n<p>&#8211; <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-12\/mdcg_2022-18_en_1.pdf\"><strong>MDCG 2022-18<\/strong><\/a> (9<sup>th<\/sup> December 2022), guideline clarifying market access requirements for <strong>legacy devices<\/strong> under Art. 97 MDR: Manufacturers and European Authorised Representatives may request that an EU Competent Authority authorise the sale of devices that are not yet fully MDR-compliant, such as legacy devices that have not yet received EC MDR certification but whose certifications under the MDD or AIMD have already expired.<\/p>\n<p>&#8211; <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-01\/mdcg_2022-21_en.pdf\"><strong>MDCG 2022-21<\/strong><\/a> (16<sup>th<\/sup> December 2022), a guideline providing different templates and methods for the preparation of the <em>Periodic Safety Update Report<\/em> (PSUR) according to MDR 2017\/745: it applies to <strong>Medical Devices certified <\/strong>under <strong>MDR<\/strong> and devices certified under <strong>MDD 93\/42\/EEC <\/strong>or <strong>AIMDD 90\/385\/EEC<\/strong>, except for those that were no longer on the EU market before the date of entry into force of MDR.<\/p>\n<p>&#8211; <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-01\/mdcg_2023-2_en.pdf\"><strong>MDCG 2022-23<\/strong><\/a> (12<sup>th<\/sup> January 2023), guideline providing a list of <em>standard fees<\/em> to be published by Notified Bodies in accordance with art. 50 of MDR and art. 46 of IVDR: in particular, this document specifies the need for Notified Bodies to make their fees publicly accessible and consultable to any public member without the need for further steps (ref. MDCG 2019-6 section V.2).<\/p>\n<p>To stay informed about updates on new MDCG guidelines and changes in the European regulatory framework, <a href=\"https:\/\/md-24.us20.list-manage.com\/subscribe?u=672feff85a65d12563810beed&amp;id=3c9da60174\"><strong>subscribe to our Newsletter<\/strong><\/a>.<\/p>\n<p><strong>&gt;&gt;&gt;<\/strong> Through our <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\"><strong>strategic-regulatory consulting<\/strong><\/a> services, <a href=\"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/\"><strong>CE certification support<\/strong><\/a> and where necessary, <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/european-authorised-representative-service\/\"><strong>European Authorized Representative<\/strong><\/a>, Thema can support you in fulfilling the requirements of the MDR (EU) 2017\/745 Medical Device Regulations.<\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/contact-us-2\/\"><strong>Contact us<\/strong><\/a> for more information.<\/p>\n<p>Sources: <a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/ip_23_23\">https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/ip_23_23<\/a><\/p>\n<p><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-01\/mdr_proposal.pdf\">https:\/\/health.ec.europa.eu\/system\/files\/2023-01\/mdr_proposal.pdf<\/a><\/p>\n<p><a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en\">https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en<\/a><\/p>\n<p><a href=\"https:\/\/www.salute.gov.it\/portale\/news\/p3_2_1_1_1.jsp?lingua=italiano&amp;menu=notizie&amp;p=dalministero&amp;id=6120\">https:\/\/www.salute.gov.it\/portale\/news\/p3_2_1_1_1.jsp?lingua=italiano&amp;menu=notizie&amp;p=dalministero&amp;id=6120<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":114,"featured_media":26427,"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-26430","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ 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