{"id":35621,"date":"2026-05-15T15:38:56","date_gmt":"2026-05-15T13:38:56","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=35621"},"modified":"2026-05-15T15:45:24","modified_gmt":"2026-05-15T13:45:24","slug":"regulation-eu-2026-977-new-rules-for-notified-bodies-on-timelines-costs-and-procedures","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2026\/05\/15\/regulation-eu-2026-977-new-rules-for-notified-bodies-on-timelines-costs-and-procedures\/","title":{"rendered":"Regulation (EU) 2026\/977: new rules for Notified Bodies on timelines, costs and procedures"},"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\"><p><strong>On 5 May 2026<\/strong>, Commission Implementing <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=OJ:L_202600977\" target=\"_blank\" rel=\"noopener\"><strong>Regulation (EU) 2026\/977<\/strong><\/a> was published, introducing a <strong>harmonised framework of quality and procedural requirements for<\/strong> the activities of <strong>Notified Bodies (NBs) <\/strong>designated under Regulation (EU) 2017\/745 (MDR) and Regulation (EU) 2017\/746 (IVDR).<\/p>\n<p>The aim is to reduce operational differences between Notified Bodies, strengthen consistency in conformity assessment, and increase the predictability of related timelines.<br \/>\nFor Manufacturers, this ensures more predictable processes, superior oversight, and a reduction in procedural timelines.<\/p>\n<h3><strong>1. Transparency on quotations and cost protection<\/strong><\/h3>\n<p>Notified Bodies will no longer be allowed to issue generic quotations. To provide a<strong> quotation<\/strong> to the Manufacturer, they must follow <strong>documented procedures<\/strong> and request <strong>standardized information<\/strong>, such as SME status (micro, small or medium-sized enterprise), the sites covered by the conformity assessment, and a detailed description of the device, to ensure that the application is properly defined from the outset.<\/p>\n<p>The quotation shall include:<\/p>\n<ul>\n<li>Estimated costs for the Quality Management System (QMS) assessment.<\/li>\n<li>Costs related to technical documentation review.<\/li>\n<li>Typical costs of surveillance activities and unannounced audits.<\/li>\n<\/ul>\n<p>More over:<\/p>\n<ul>\n<li>NB shall inform the manufacturer in advance of any cost increase exceeding 10% compared to the initial estimate.<\/li>\n<li>Any such increase must be duly justified.<\/li>\n<\/ul>\n<h3><strong>2. Timelines for conformity assessment<br \/>\n<\/strong><\/h3>\n<p>The Regulation introduces mandatory <strong>maximum time limits <\/strong>for the main stages of the conformity assessment.<\/p>\n<p><strong>Application review and contract signature:<\/strong><\/p>\n<ul>\n<li>Maximum 30 days.<\/li>\n<li>The timeline starts on the day NB receives a complete application and ends with the signature of the contract.<\/li>\n<\/ul>\n<p><strong>QMS Audit:<\/strong><\/p>\n<ul>\n<li>Maximum 120 days.<\/li>\n<li>The period runs from the start of the first audit activity to the completion of the final review.<\/li>\n<\/ul>\n<p><strong>Technical documentation assessment:<\/strong><\/p>\n<ul>\n<li>Maximum 90 days.<\/li>\n<li>The deadline ends with the final review of the technical documentation.<\/li>\n<\/ul>\n<p><strong>Decision and issuance of the certificate:<\/strong><\/p>\n<p>Maximum 20 days.<\/p>\n<p>The timeline runs from the day after the completion of the final review and ends with the issuance of the certificate and its registration in Eudamed.<\/p>\n<h3><strong>3. Management of timeline interruptions (clock-stops)<\/strong><\/h3>\n<p><strong>Timeline interruptions<\/strong> <strong>for clarification requests or additional information<\/strong> from the NB will be <strong>limited in number<\/strong>.<\/p>\n<p>The Regulation allows:<\/p>\n<ul>\n<li>A maximum of one interruption for the application review and contract signature phase;<\/li>\n<li>A maximum of four interruptions for the QMS audit phase;<\/li>\n<li>A maximum of four interruptions for the technical documentation assessment phase.<\/li>\n<\/ul>\n<p>The aim is to reduce delays and timelines perceived as excessively long by stakeholders in the sector.<\/p>\n<h3><strong>4. Certificate renewals: streamlined procedures and predictable timelines<\/strong><\/h3>\n<p>For recertification (certificate renewal), Notified Bodies must <strong>avoid repeating assessments already carried out during the initial certification.<\/strong><\/p>\n<p>The review must focus in particular on <strong>changes<\/strong> to the device or the Quality Management System, results from post-market surveillance activities, and real-world data derived from the post-market phase. The assessment must also take into account the state of the art and the evolution of the device\u2019s risk profile.<\/p>\n<p><strong>Renewal timelines:<\/strong><\/p>\n<ul>\n<li>Documentation review must be completed within a maximum of 90 days from receipt of the application.<\/li>\n<li>The final decision and re-issuance of the certificate must take place within 20 days of the final review.<\/li>\n<\/ul>\n<h3><strong>5. Public performance monitoring<\/strong><\/h3>\n<p>Notified Bodies will be required to <strong>publish reports<\/strong> containing information on conformity assessment timelines and the alignment between quotations and actual costs applied. This reporting mechanism is intended to enhance <strong>transparency<\/strong> and enable manufacturers to compare the performance of different Notified Bodies.<\/p>\n<h3><strong>6. Application<\/strong><\/h3>\n<p>The Regulation will apply <strong>from 25 February 2027.<\/strong> However, specific transitional provisions have been established to ensure a smooth adaptation for both Notified Bodies and Manufacturers. For a comprehensive overview of the specific transitional measures and effective dates &#8211; including exceptions for existing contracts and certificate renewals &#8211; please refer to <strong>Articles 8 and 9<\/strong> <strong>of the Regulation.<\/strong><\/p>\n<p><strong>SOURCE:<\/strong><br \/>\n<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=OJ:L_202600977\" target=\"_blank\" rel=\"noopener\"><strong>Regolamento di esecuzione (UE) 2026\/977<\/strong><\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":35632,"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-35621","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\/ -->\n<title>Regulation (EU) 2026\/977: new rules for Notified Bodies on timelines, costs and procedures - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" 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