{"id":29794,"date":"2023-08-02T11:55:03","date_gmt":"2023-08-02T09:55:03","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=29794"},"modified":"2023-08-04T12:09:01","modified_gmt":"2023-08-04T10:09:01","slug":"uk-template-letter-published-for-mdr-extension-alignment","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2023\/08\/02\/uk-template-letter-published-for-mdr-extension-alignment\/","title":{"rendered":"UK: template letter published for MDR extension alignment"},"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-blend:overlay;--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 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">On 3 July 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) published on its official website the <em><a href=\"https:\/\/www.thema-med.com\/en\/contact-us-2\/\">EU MDR Article 120 extension confirmation<\/a><\/em>, a <strong>template of the letter<\/strong> to be submitted by Manufacturers to align with Article 120 of the MDR Regulation (EU) 2017\/745.<\/h2>\n<p>This document is not a guideline but a declaration by the manufacturer: the latter must fill in the form indicating under which condition he can benefit from the extension.<\/p>\n<p>The following is a reminder of the <strong>conditions<\/strong> that must be fulfilled for the extension of the validity of an EC certificate under Article 120 and which allow the device to be marketed in the UK.<\/p>\n<ul>\n<li>In the case of certificates that expired before 20\/03\/2023, the manufacturer has a <strong>signed contract<\/strong> with a Notified Body that precedes the original expiry of the certificate;<\/li>\n<li>In the case of certificates that expired before 20\/03\/2023 and where no contract has been signed between the manufacturer and the Notified Body, the former may benefit from the extension if:\n<ul>\n<li>receives a derogation from conformity assessment procedures under <strong>Article 59<\/strong> of the MDR, or<\/li>\n<li><strong>conformity assessment<\/strong> under Article 97 of the MDR is carried out.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&gt;&gt;&gt;If you want to market Medical Devices and IVDs in the UK, Thema can assist you with the <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">Strategic Regulatory Consulting<\/a><\/strong> Service, be appointed <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/uk-responsible-person-service\/\">UK Responsible Person (UKRP)<\/a><\/strong> of the organisation and support you in <strong>registering products<\/strong> with MHRA.<\/p>\n<p><strong>Source<\/strong><\/p>\n<p><a href=\"https:\/\/lnkd.in\/d9QvBRYG\">EU MDR Article 120 extension confirmation<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":29790,"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-29794","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 - 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