Navigating Medical Device Repair Regulations in the US and Canada

This year, varying forms of right to repair legislation have been considered in nearly 30 US states. The legislation impacts multiple business and product sectors, from automobiles to healthcare.

Now, the right to repair discussion is gaining momentum in Canada as well. But the message is still the same, not all industries should be treated with equal considerations.

In Canada, the right to repair debate is primarily centered around copyright laws. Bill C-244 aims to modify the Copyright Act, allowing for the circumvention of technological protection measures exclusively to diagnose, maintain, or repair specific products.

The debate is like what we are seeing with the Digital Millennium Copyright Act and Library of Congress here in the U.S. The Librarian can issue exemptions to a law within the DMCA that prohibits breaking software copy protection (you can read more about this topic in our previous blog).

Bill C-244 marks a pivotal advancement in Canada’s legislative journey toward embracing the right-to-repair movement and consumption patterns. This initiative aligns with the Canadian government’s recent consultations to bolster a circular economy which is an important issue. But it is imperative for Canadian lawmakers to consider all aspects of the legislation’s potential impact if kept broad, especially when it comes to putting the integrity of medical devices in jeopardy.

Minimal support behind the issue became evident after Ontario’s failed attempt at passing right to repair legislation in 2019. Then, initial efforts to dismantle copyright restrictions impeding repairs due to digital locks on software were embodied in Bill C-272 of 2021, which faltered but was later reintroduced as Bill C-244 in February 2022. After that, amendments in May 2023 have muddled its reach and impact. However, in recent weeks, Bill C-244 has begun to take center stage, passing the House of Commons in the latter part of 2023 and has been under consideration by the Senate since May 2024.

Of all the devices in the world, medical devices are the last instruments that should be receiving servicing shortcuts. Their intricate parts and cybersecurity systems need expert oversight and regulated repairs. Allowing medical equipment to fall under right to repair will allow untrained and unregulated third parties to perform these repairs instead, threatening patient safety. Hospital-based biomedical engineering technologists with formal qualifications, regulations and training should be the ones responsible for the upkeep, repair, and maintenance of medical devices.

While supporting consumer rights and e-waste reduction through the right-to-repair movement is commendable, its application to medical devices without restrictions could pose significant dangers.