{"id":1977,"date":"2024-08-01T16:12:15","date_gmt":"2024-08-01T16:12:15","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=1977"},"modified":"2024-10-18T07:25:15","modified_gmt":"2024-10-18T07:25:15","slug":"new-artificial-intelligence-law-comes-into-force-today-august-1-2024-key-points-and-focus-on-high-risk-devices-cloned","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/new-artificial-intelligence-law-comes-into-force-today-august-1-2024-key-points-and-focus-on-high-risk-devices-cloned\/","title":{"rendered":"New Artificial Intelligence Law Comes Into Force Today, August 1, 2024: Key Points and Focus on High-Risk Devices"},"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><span style=\"color: var(--awb-text-color); font-family: var(--awb-text-font-family); font-size: var(--awb-font-size); font-style: var(--awb-text-font-style); font-weight: var(--awb-text-font-weight); letter-spacing: var(--awb-letter-spacing); text-align: var(--awb-content-alignment); text-transform: var(--awb-text-transform); background-color: var(--awb-bg-color-hover);\">The European Parliament and the Council of the European Union have approved Regulation (EU) 2024\/1689, establishing a uniform legal framework for the development, commercialization, and use of artificial intelligence (AI) systems across the European Union. The primary aim of this regulation is to promote human-centric AI, ensuring safety, health protection, and fundamental rights while fostering innovation and competitiveness within the internal market.<\/span><\/p>\n<p><b>Specific Requirements for Medical Devices with AI<\/b><\/p>\n<p><b>Conformity Assessment:<\/b> Before a medical device with AI can be marketed in the EU, it must undergo a rigorous conformity assessment process. This includes extensive testing to ensure the system is safe and complies with all applicable legal requirements.<\/p>\n<p><b>Transparency and Explainability:<\/b> Developers of these devices must ensure that the AI-generated outcomes are explainable and understandable to healthcare professionals, facilitating informed decision-making.<\/p>\n<p><b>Continuous Monitoring: <\/b>Once the device is in use, continuous monitoring is required to detect and mitigate any risks that may arise during its operation, ensuring the device\u2019s safety and effectiveness over time.<\/p>\n<p><b>Data Protection: <\/b>Medical devices with AI must adhere to strict data protection standards, ensuring the privacy and security of patient information.<\/p>\n<p>This regulation marks a milestone in the regulation of artificial intelligence in Europe, aiming to balance citizen protection with the promotion of technological innovation in key sectors such as healthcare.<\/p>\n<p>If you believe your product needs to comply with the new EU regulations, CMC can provide you with the guidance needed to ensure your products can be safely marketed in Europe.<\/p>\n<\/div><div ><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\" target=\"_self\" href=\"https:\/\/cmcmedicaldevices.com\/services\/consulting-mdr\/\"><span class=\"fusion-button-text\">MDR CONSULTING<\/span><\/a><\/div><div class=\"fusion-text fusion-text-2\"><p>&nbsp;<\/p>\n<\/div><div class=\"fusion-image-element \" 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https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/08\/95733_42482_710.jpg 600w\" sizes=\"(max-width: 640px) 100vw, 600px\" \/><\/span><\/div><\/div><\/div><\/div><\/div>\n\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-center kksr-valign-bottom\"\n    data-payload='{&quot;align&quot;:&quot;center&quot;,&quot;id&quot;:&quot;1977&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;bottom&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;0&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;0&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;Rate this&quot;,&quot;legend&quot;:&quot;0\\\/5 - (0 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;New Artificial Intelligence Law Comes Into Force Today, August 1, 2024: Key Points and Focus on High-Risk Devices&quot;,&quot;width&quot;:&quot;0&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        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