{"id":3185,"date":"2024-12-16T12:35:01","date_gmt":"2024-12-16T12:35:01","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3185"},"modified":"2024-12-16T12:35:01","modified_gmt":"2024-12-16T12:35:01","slug":"public-consultation-on-the-evaluation-of-eu-regulations-for-medical-devices-and-in-vitro-diagnostics-have-your-say","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/public-consultation-on-the-evaluation-of-eu-regulations-for-medical-devices-and-in-vitro-diagnostics-have-your-say\/","title":{"rendered":"Public Consultation on the Evaluation of EU Regulations for Medical Devices and In Vitro Diagnostics: Have Your Say!"},"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>The European Commission has initiated a <b>public consultation<\/b> to assess the effectiveness, efficiency, relevance, and coherence of the EU regulations on medical devices (Regulation 2017\/745) and in vitro diagnostic devices (Regulation 2017\/746). This is a key opportunity for stakeholders to help shape the future of medical device regulations in Europe, ensuring that they continue to prioritize patient safety while supporting innovation.<\/p>\n<p><b>Why Participate?<br \/>\n<\/b><br \/>\nThe European Commission is evaluating the implementation of these regulations since their adoption in 2017, examining how well they address current and future needs. The consultation seeks to gather<b> evidence <\/b>and <b>data<\/b> from various stakeholders, including <b>economic operators, regulatory authorities, healthcare professionals, patient and consumer organizations, and academic experts.<br \/>\n<\/b><br \/>\nThe aim is to evaluate whether the regulations are:<\/p>\n<ul>\n<li><b>Effective and efficient<\/b>, ensuring the availability of safe and innovative devices on the European market.<\/li>\n<li><b>Proportionate<\/b>, balancing costs and benefits, particularly for SMEs.<\/li>\n<li><b>Aligned<\/b> with EU policies on health, digitalization, and the environment.<\/li>\n<\/ul>\n<p><b>Who Can Participate? <\/b>This consultation is open to a broad range of stakeholders, including:<\/p>\n<ul>\n<li>EU\/EEA Member States&#8217; competent authorities.<\/li>\n<li>Independent bodies that assess the conformity of medical devices.<\/li>\n<li><b>Economic operators<\/b> and <b>healthcare professionals<\/b> associations.<\/li>\n<li><b>Patient <\/b>and <b>consumer <\/b>organizations.<\/li>\n<li><b>Academic researchers<\/b> and <b>scientific bodies<\/b>.<\/li>\n<li>International organizations and <b>non-EU\/EEA countries<\/b>.<\/li>\n<\/ul>\n<p><b>Key Information<\/b>: The consultation will run <b>from December 12, 2024, to March 21, 2025<\/b>, and will offer various ways to contribute, including:<\/p>\n<ul>\n<li>A <b>Call for Evidence<\/b> in all EU official languages.<\/li>\n<li><b>Public consultations <\/b>with questionnaires.<\/li>\n<li><b>Workshops <\/b>and stakeholder conferences.<\/li>\n<\/ul>\n<p>If you are involved in the medical device sector, this is your chance to share your insights and influence the future of EU regulations.<\/p>\n<p><b>Get Involved Today!<\/b> To learn more and access the full consultation document,<b> <u><a href=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/12\/090166e5160b4683-3.pdf\">download here the full document<\/a><\/u><\/b>.<\/p>\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:10px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us for more information<\/span><\/a><\/div><div class=\"fusion-image-element \" style=\"--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\"><a 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