Medical device regulation is being tested by a pace and diversity of innovation that existing policy frameworks were not designed to accommodate. Health monitoring wearables increasingly blur the line between wellness products and medical tools, while medical artificial intelligence demands specialized methods for generating evidence and anticipating emerging risks. Yet regulation, beyond responding to technological novelty, must provide consistent pathways that allow promising technologies to be studied, assessed and brought to patients efficiently by foreseeing and pre-empting hurdles. In this issue of Nature Biomedical Engineering, four Comments approach this problem from complementary perspectives and describe different angles of the fragmented landscape in the USA and Europe for regulating both wellness and medical devices.
There is a blurred line between wellness and medical devices, which may shift responsibilities from device manufacturers onto consumers and clinicians. A Comment from Dunn and colleagues critically examines the implications of the 2026 US Food and Drug Administration (FDA) guidance on wellness devices. In it, the authors note that digital health technologies, such as wearables and sensor-based consumer devices, go well beyond generating large amounts of data on their wearers’ physiologies and risk unpredictably reshaping the practice of medicine. Through a careful dissection of the new guidance, the authors point towards safer regulatory strategies, such as establishing reporting standards and distinct validation strategies for wellness devices to support their responsible evolution.
A Comment from Brasier, Goldhahn and colleagues also takes on the regulatory governance of wearable technologies, how these policies depend on whether the manufacturer seeks certification as a medical device or designation as a wellness device, and how different regulatory guidance across nations can impact innovation and deployment. The authors note that an end result of current policies could leave wearable users and clinicians around the world in uncharted territories where the burden of verifying unvalidated consumer health data is placed upon an unprepared healthcare system. To address this problem, the authors propose a shift from a device-centric to a data-centric regulatory model for wellness devices to enable the use of consumer-generated healthcare data without forcing hardware reclassification of mass-market products. The overarching goal is to promote the establishment of standards for wellness devices that remain compatible with medical device regulations in Switzerland, the European Union (EU) and the USA.
Focusing on medical devices, a Comment from Kolbinger and colleagues describes how EU regulatory policy on medical devices is fragmented across member states, which can both create barriers to innovation and slow the pace of potentially life-saving technologies entering the clinic. The piece highlights how vague language in regulatory policy regarding a specific requirement of “other clinical investigations” for regulatory approval creates uncertainty that disproportionately affects academic investigators, start-ups, and small and medium-sized enterprises in a way that could limit multinational studies and, more broadly, innovation in the EU. The authors stress that legislative reform should deliver a harmonized and predictable framework that balances safety and innovation.
Finally, Schönfelder and colleagues present a Comment that also critically examines EU regulatory policy regarding medical devices. The authors stress that existing regulatory frameworks, which rely heavily on set precedent and long-established regulatory domains, are failing to adapt to the rate of technological innovation in both physical and digital medical devices. They identify EU-specific regulatory practices that may be holding back innovation and propose that the EU adopt a coordinated regulatory science approach, Centres of Excellence in Regulatory Science and Innovation (CERSIs), which have already been successfully established in the USA and the UK. These independent research bodies, which involve collaboration across academic institutions and governmental agencies, seek to not only improve regulatory guidance but to further advance regulatory science itself in order to help ensure that regulatory guidance can adapt over time in response to new technologies.
Advances in medical technologies are evolving too quickly and affecting health too directly for regulatory systems to remain fragmented, ambiguous and reactive. Clearer boundaries, harmonized requirements and stronger regulatory science institutions should not be bureaucratic luxuries, but prerequisites for trustworthy innovation. Although the Comments in this issue are focused on the USA and Europe, we urge regulators and legislators around the world to pursue reform with urgency, ensuring that scientific rigour, patient protection and access advance together rather than at one another’s expense, keeping in mind that policy should reflect how both wellness and medical devices are increasingly used in practice.
source: nature.com
