{"id":6917,"date":"2019-02-27T16:04:39","date_gmt":"2019-02-27T15:04:39","guid":{"rendered":"https:\/\/productosanitario.es\/medical-device-requirements\/"},"modified":"2025-03-06T15:45:28","modified_gmt":"2025-03-06T14:45:28","slug":"medical-device-requirements","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/medical-device-requirements\/","title":{"rendered":"Medical Device Requirements"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6917\" class=\"elementor elementor-6917 elementor-2768\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-35cdbb9 e-con-full e-flex e-con e-parent\" data-id=\"35cdbb9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-c56b03e e-con-full e-flex e-con e-child\" data-id=\"c56b03e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2f3061b elementor-widget elementor-widget-heading\" data-id=\"2f3061b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\"><b>Medical Device<\/b> Requirements<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1d9e93e elementor-widget elementor-widget-text-editor\" data-id=\"1d9e93e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The requirements, or <a href=\"https:\/\/productosanitario.es\/category\/producto-sanitario\/requisitos-generales-rgsf\/\" target=\"_blank\" rel=\"noopener\">general safety and performance requirements<\/a> under Regulation 2017\/745 (<a href=\"https:\/\/productosanitario.es\/category\/mdr-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\">MDR<\/a>) and Regulation 2017\/746 (<a href=\"https:\/\/productosanitario.es\/category\/ivdr-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\">IVDR),<\/a> are generally described as the need to fulfil the <a href=\"https:\/\/www.productosanitario.es\/finalidad-prevista\" target=\"_blank\" rel=\"noopener\">intended purpose<\/a> specified by the manufacturer with the highest possible degree of safety and effectiveness.<\/p><p>The <a href=\"https:\/\/www.productosanitario.es\/producto-sanitario\" target=\"_blank\" rel=\"noopener\">products<\/a> will not compromise the clinical condition or safety of patients, and the possible residual risks will always be acceptable in relation to their benefit, that is, always maintaining a positive risk-benefit ratio.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0067dc6 e-con-full e-flex e-con e-child\" data-id=\"0067dc6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f2c3857 e-flex e-con-boxed e-con e-parent\" data-id=\"f2c3857\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f210529 e-con-full e-flex e-con e-child\" data-id=\"f210529\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-00d7060 e-con-full e-flex e-con e-child\" data-id=\"00d7060\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fb943e1 elementor-widget elementor-widget-text-editor\" data-id=\"fb943e1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"https:\/\/productosanitario.es\/category\/eudamed\/actores-economicos-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">Manufacturers<\/a> must design, implement, document, and maintain a risk analysis and management system:<\/p><ul><li>Risk <a href=\"https:\/\/productosanitario.es\/en\/risk-management\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">management<\/a> plan for each product.<\/li><li>Analysis of known and foreseeable risks for each product.<\/li><li>Risk assessment in the intended use and in the foreseeably improper use.<\/li><li>Assessment of the impact of the information collected by the <a href=\"https:\/\/www.productosanitario.es\/sistema-de-vigilancia\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">monitoring system<\/a>.<\/li><li>It shall amend the control measures based on the previous impact assessment.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-abc47c3 e-flex e-con-boxed e-con e-parent\" data-id=\"abc47c3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d471ca6 elementor-widget elementor-widget-text-editor\" data-id=\"d471ca6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The risk control measures adopted by <a href=\"https:\/\/productosanitario.es\/category\/eudamed\/actores-economicos-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">manufacturers<\/a> for the design and manufacture of products shall be in accordance with the principles of safety, taking into account the state of the art, managing the residual risk until they are considered acceptable:<\/p><ul><li>With safe design and manufacturing, risks will be eliminated or reduced.<\/li><li>Appropriate protection measures shall be adapted against risks that cannot be eliminated.<\/li><li>Safety information, including user training, will be provided if necessary.<\/li><li>Manufacturers shall inform users of residual risks.<\/li><\/ul><p class=\"pagetitle-text pagetitle__pagetitle-text\">By eliminating or reducing the risks associated with errors of use, the manufacturer will:<\/p><ul><li>It will reduce risks related to the ergonomics and intended environment of the product.<\/li><li>It shall take into account the technical knowledge, experience, education, training and environment of use of the users, as well as their medical and physical condition.<\/li><\/ul><p>During the life of the <a href=\"https:\/\/www.productosanitario.es\/producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">product<\/a>, the characteristics and its operation will not pose a danger to patient safety under normal conditions of use and maintenance.<\/p><p><a href=\"https:\/\/www.productosanitario.es\/producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">The products <\/a>shall be designed, manufactured and packaged in such a way that transport and storage do not pose a risk.<br>All known and foreseeable risks, including undesirable side effects, shall be reduced and acceptable in relation to the benefit.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ab0d1a4 e-flex e-con-boxed e-con e-parent\" data-id=\"ab0d1a4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3cc358b elementor-widget elementor-widget-heading\" data-id=\"3cc358b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Blog<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5da69b9 elementor-grid-tablet-3 elementor-widget__width-inherit elementor-grid-3 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"5da69b9\" data-element_type=\"widget\" data-e-type=\"widget\" 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elementor-widget-heading\" data-id=\"cf19537\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Contact<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0174c9 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"c0174c9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Write to us at<br><a href=\"mailto:info@productosanitario.es\"><span style=\"text-decoration: underline; color: #ffffff;\">info@productosanitario.es<\/span><\/a> <br>voice call or Whatsapp<br><span style=\"color: #ffffff;\">+34 669 27 21 63<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bb888e6 e-con-full e-flex e-con e-child\" data-id=\"bb888e6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b86b8c1 elementor-widget elementor-widget-heading\" data-id=\"b86b8c1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">or fill out our form.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17df433 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"17df433\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/productosanitario.es\/en\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Form<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Medical Device Requirements The requirements, or general safety and performance requirements under Regulation 2017\/745 (MDR) and Regulation 2017\/746 (IVDR), are generally described as the need to fulfil the intended purpose specified by the manufacturer with the highest possible degree of safety and effectiveness. The products will not compromise the clinical condition or safety of patients, [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-6917","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical Device Requirements - Consultor\u00eda de producto sanitario<\/title>\n<meta name=\"description\" content=\"The general safety and performance requirements are the requirements that every medical device must meet\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/productosanitario.es\/en\/medical-device-requirements\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Requirements - 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