The “Right to Repair” (RtR) movement is not limited to the USA but it is a worldwide crusade aimed at reducing costs, toxic waste and global climate change. In the particular field of medical equipment (a subset of medical devices), several countries are either ahead of the USA or progressing rapidly as shown below.
In 1993, EU established the Medical Device Directive (MDD)[1], which states in its Annex I
13. Information supplied by the manufacturer
§ …
§ 13.6 Where appropriate, the instructions for use must contain the following particulars:
…
(d) all the information needed to verify whether the device is properly installed and can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times;
In 2017, MDD was superseded by Medical Device Regulation (MDR)[2], which states in its Annex I
23. Label and instructions for use
§ … 23.4. Information in the instructions for use
…
(k) the information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant
…
details of the nature, and frequency, of preventive and regular maintenance, and of any preparatory cleaning or disinfection
Footnote:
[1] Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042
[2] Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
In 2016 the State Food and Drug Administration issued Order No. 18 entitled “Measures for the Supervision and Administration of quality of the use of medical devices,” [3] stating:
Article 17 The unit using medical devices may, in accordance with the provisions of the contract, require the medical device production and trading enterprises to provide medical device maintenance and repair services, and may also entrust a maintenance service institution with conditions and capabilities to carry out medical device maintenance and repair, or carry out maintenance and repair of the medical devices in use on their own.
If the medical device user entrusts the maintenance service agency or carries out maintenance and repair of the medical device in use on its own, the medical device production and operation enterprise shall provide the preventive maintenance manual, corrective maintenance manual, software backup, fault code table, spare parts list, parts, maintenance password and other materials and information necessary for maintenance and repair in accordance with the contract.
Furthermore, in 2019 the National Medical Products Administration updated the 2014 “Provisions for Instructions and Labels of Medical Devices (Decree No.6 of China Food and Drug Administration)”[4] stating:
Article 3 Medical device instructions refer to those technical documents that are formulated by registrants or filing entities of medical devices, provided to users together with the products, covering their basic safety and effectiveness information, to guide the correct installation, testing, operation, use, repair and maintenance of products
Article 10 In general, the following content shall be included in medical device instructions:
…
(9) Product repair and maintenance methods, special conditions and methods for storage and transportation
Footnote:
[3] Available only in Chinese at https://www.nmpa.gov.cn/ylqx/ylqxfgwj/ylqxbmgzh/20151021120001725.html
[4] Available at https://english.nmpa.gov.cn/2019-10/11/c_415402.htmhttps://english.nmpa.gov.cn/2019-10/11/c_415402.htm
A 2-day Convention called “2026 Canadian Repair Convention” was held May 21-22, 2026 in Halifax, Nova Scotia, with numerous presentations and demonstrations covering Right to Repair of many consumer and professional products, including medical equipment. Three speakers on RtR for medical devices represented the Canadian Medical & Biological Engineering Society (CMBES), Canadian Armed Forces, and Nova Scotia Health. Session recordings and more information are available at https://www.canadianrepairconvention.ca/home.
A position statement from the Canadian Medical and Biological Engineering Society (CMBES) is available at: https://www.cmbes.ca/clinical-biomedical-engineering/publications-resources/position-statements/right-to-repair
The Australian government’s Productivity Commission conducted an inquiry in 2021 into the Right to Repair of several consumer and professional products. In its December 2021 report [5], it uncovered concerns “product manufacturers are using their strong position in the repair markets for their products to impede access to these repair supplies,” including medical devices, and made this recommendation:
“The Australian Government should conduct an independent public review of existing medical device regulations to assess whether they strike a balance between repair access and device safety that maximises community wellbeing. The review should consider whether current regulations create incentives for manufacturers to restrict repair, and examine potential ways to improve repair access for low-risk medical devices or for highly-qualified independent repair technicians.
Footnote:
[5] Available at https://www.pc.gov.au/inquiries-and-research/repair/report/
On October 13, 2025, Italian independent service organizations (ISOs) founded the “Associazione Italiana Manutenzione Apparecchiature Biomedicali” (AISAB) congregating ~3,000 highly qualified professionals. AISAB’s mission is to “represent the interests of independent providers through an ethical and transparent structure focused on quality, safety, and sustainability. “ [6]
According to AISA, the critical issues to be addressed in Italy and EU are:
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.
Footnote:
[6] More information is available at https://aisab.it/en/