Regulatory Stringency and Impacts on Equity and Innovation in Medical Devices: Insights from the EU MDR 2017 and Considerations for the FDA

The new EU Medical Device Regulations (MDR), originally put forth in 2017, aimed to improve medical device safety in light of regulatory failures. However, although the MDR have improved safety requirements, they have inadvertently created barriers for innovation which have disproportionately impacted small and medium-sized enterprises (SMEs) and orphan device manufacturers. This commentary explores the unintended consequences of the EU MDR as a cautionary case study for the U.S. Food and Drug Administration (FDA), emphasizing the need to balance regulations. In particular, this commentary discusses the mechanisms by which increased evidence requirements, extended approval timelines, and increased costs have led to market contraction which threaten patient health. Creative solutions are proposed including provisional approvals, subsidized applications, and international recognition agreements. The implications and precedent set by the MDR are used to forewarn emerging regulations in artificial intelligence-enabled medical devices.