Manifesto AISAB
Italian Association of Biomedical Equipment Services
October 13, 2025
Why AISAB Was Created
The Italian market for integrated services and maintenance for biomedical and Diagnostic Imaging technologies involves over 3,000 highly qualified professionals.
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.
The COVID-19 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.
AISAB was created from the need to establish an institutional partner 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.
THE CONTEXT AND THE "RIGHT TO REPAIR" CHALLENGE
In recent years, the international movement for the right to repair has brought to light a crucial issue: the freedom of owners and technicians to service and maintain devices ensuring their full functionality.
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.
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.
AISAB was created to assert that maintenance is an integral part of care—and that an efficient healthcare system must guarantee the freedom to repair safely.
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.
INTERNATIONAL INSPIRATION
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.
Their joint action contributed to the introduction of the Critical Medical Infrastructure Right-to-Repair Act (2020) and the recognition by the Federal Trade Commission of the importance of competition in maintenance services.
The American experience demonstrates that collective and coordinated action can change market rules. AISAB intends to bring this model to Europe and Italy.
THE EUROPEAN AND ITALIAN REGULATORY CONTEXT
In Europe, Directive (EU) 2024/1799 on the Right to Repair introduced new protections for consumer goods, but excluded medical devices, creating a regulatory gap that generates uncertainty among healthcare facilities and operators.
Regulation (EU) 2017/745 (MDR) 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 judicial rulings recognizing the right of intervention for qualified third parties.
AISAB aims to support efforts to fill this regulatory gap, working toward modern, balanced regulation geared toward the sustainability of the healthcare system.
CRITICAL ISSUES TO ADDRESS
The Italian biomedical services market currently presents several obstacles that require coordinated intervention:
- Restrictive contractual conditions that impose certifications or constraints.
- Access to spare parts and software, which—while respecting intellectual property—should be guaranteed to all operators with competitive delivery times.
- Technical documentation sometimes granted with restrictive clauses.