{"id":584,"date":"2026-07-20T14:47:26","date_gmt":"2026-07-20T14:47:26","guid":{"rendered":"https:\/\/aisab.it\/manifesto\/"},"modified":"2026-09-10T12:42:37","modified_gmt":"2026-09-10T12:42:37","slug":"manifesto","status":"publish","type":"page","link":"https:\/\/aisab.it\/en\/manifesto\/","title":{"rendered":"MANIFESTO"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"584\" class=\"elementor elementor-584 elementor-155\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0e298fb e-flex e-con-boxed e-con e-parent\" data-id=\"0e298fb\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7ae15af elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"7ae15af\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Manifesto AISAB<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d378783 elementor-widget elementor-widget-text-editor\" data-id=\"d378783\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><em>Italian Association of Biomedical Equipment Services<\/em><br \/><strong>October 13, 2025<\/strong> <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-24a26ef e-con-full e-flex e-con e-child\" data-id=\"24a26ef\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-68f1f38 elementor-widget elementor-widget-heading\" data-id=\"68f1f38\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why AISAB Was Created\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-121d097 elementor-widget elementor-widget-text-editor\" data-id=\"121d097\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400\">The Italian market for integrated services and maintenance for biomedical and Diagnostic Imaging technologies involves over <strong>3,000 highly <strong>qualified professionals.<\/strong><\/strong><\/p><p>The biomedical equipment sector is undergoing a period of profound transformation driven by increasing technological complexity. The rapid adoption of new technologies together with the growing requirements related to cybersecurity, AI, and software evolution make maintenance a strategic area where operational efficiency, access, and responsiveness are increasingly vital.<\/p><p>The <strong>COVID-19<\/strong> pandemic highlighted certain systemic vulnerabilities: hospitals and industry operators encountered difficulties in effectively maintaining biomedical and diagnostic equipment, with a direct impact on the readiness and efficiency of healthcare responses. <\/p><p><strong>AISAB<\/strong> was created from the need to establish an <strong>institutional partner<\/strong> to enable clinical engineers and independent operators of integrated services and maintenance to achieve the effectiveness and efficiency required by healthcare facilities for the management of a complex and constantly evolving equipment fleet.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-47a68e2 elementor-widget elementor-widget-heading\" data-id=\"47a68e2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">THE CONTEXT AND THE \"RIGHT TO REPAIR\" CHALLENGE \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-27447a0 elementor-widget elementor-widget-text-editor\" data-id=\"27447a0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400\">In recent years, the international movement for the <strong>right to repair<\/strong> has brought to light a crucial issue: the freedom of owners and technicians to service and maintain devices ensuring their full functionality.<\/p><p style=\"font-weight: 400\">In the biomedical sector, this freedom remains partial because right-to-repair regulations have not been implemented in the medical field, leaving regulatory gaps that create uncertainty for operators.<\/p><p style=\"font-weight: 400\">During the COVID-19 pandemic, many Italian hospitals experienced firsthand the consequences of these restrictions: life-saving equipment locked down due to a lack of spare parts or documentation, repair delays, and difficulties in sourcing qualified training.<\/p><p style=\"font-weight: 400\">AISAB was created to assert that maintenance is an integral part of care\u2014and that an efficient healthcare system must guarantee the <strong>freedom to repair safely.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b97fcec elementor-widget elementor-widget-text-editor\" data-id=\"b97fcec\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><em>AISAB is the Italian response to the need to ensure freedom of maintenance, technical access, and the protection of the right to repair in the healthcare sector as well.<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-08ada1e elementor-widget elementor-widget-heading\" data-id=\"08ada1e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">INTERNATIONAL INSPIRATION \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-31a7c1c elementor-widget elementor-widget-text-editor\" data-id=\"31a7c1c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400\">AISAB is inspired by the US-based Alliance project (Alliance for Quality Medical Device Servicing), which has represented leading American companies in the sector since 2018.<\/p><p style=\"font-weight: 400\">Their joint action contributed to the introduction of the <strong>Critical Medical Infrastructure Right-to-Repair Act (2020)<\/strong> and the recognition by the <strong>Federal Trade Commission<\/strong> of the importance of competition in maintenance services.<\/p><p>The American experience demonstrates that <strong>collective and coordinated action can change market rules.<\/strong> AISAB intends to bring this model to Europe and Italy.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aee24b6 elementor-widget elementor-widget-heading\" data-id=\"aee24b6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">THE EUROPEAN AND ITALIAN REGULATORY CONTEXT \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a19a93a elementor-widget elementor-widget-text-editor\" data-id=\"a19a93a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>In Europe, <b>Directive (EU) 2024\/1799 on the Right to Repair<\/b> introduced new protections for consumer goods, but excluded <b>medical devices<\/b>, creating a regulatory gap that generates uncertainty among healthcare facilities and operators.<br><br><b>Regulation (EU) 2017\/745 (MDR)<\/b> establishes the need to ensure safety and performance, but its restrictive application by some manufacturers limits access to essential information and tools. In Italy, specific rules are still lacking, despite <b>judicial rulings<\/b> recognizing the right of intervention for qualified third parties.<br><br>AISAB aims to support efforts to fill <b>this regulatory gap<\/b>, working toward modern, balanced regulation geared toward the sustainability of the healthcare system.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4e64979 elementor-widget elementor-widget-heading\" data-id=\"4e64979\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">CRITICAL ISSUES TO ADDRESS \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3b15a75 elementor-widget elementor-widget-text-editor\" data-id=\"3b15a75\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"font-weight: 400\">The Italian biomedical services market currently presents several obstacles that require coordinated intervention:<\/p><ul style=\"font-weight: 400\"><li><strong>Restrictive contractual conditions<\/strong> that impose certifications or constraints.<\/li><li><strong>Access to spare parts and software<\/strong>, which\u2014while respecting intellectual property\u2014should be guaranteed to all operators with competitive delivery times.<\/li><li><strong>Technical documentation<\/strong> sometimes granted with restrictive clauses.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3dbab9b elementor-widget elementor-widget-heading\" data-id=\"3dbab9b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">AISAB is committed to giving a voice to these critical issues, promoting shared and sustainable solutions. <\/h2>\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>Manifesto AISAB Italian Association of Biomedical Equipment ServicesOctober 13, 2025 Why AISAB Was Created The Italian market for integrated services 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