Opportunities for advancing paediatric medical device access: regulatory frameworks in the EU and USA.

Paediatric medical device development lags substantially behind that for adults, creating inequities in access to age-appropriate care. Current regulatory frameworks ensure patient safety but impose structural barriers to device availability. In this Health Policy, we analyse decentralised EU and centralised US regulatory approaches to identify opportunities for reform. A scoping review and analysis of 40 paediatric-specific stakeholder responses to the European Commission's 2024 targeted consultation on the impact of the Medical Device Regulation and the In Vitro Diagnostic Devices Regulation revealed major shortcomings. In the EU, 29 (73%) of 40 stakeholders cited device availability problems, 22 (55%) need for regulatory reform, and 19 (48%) certification barriers, despite emerging paediatric-specific incentives. The USA's centralised oversight, facilitative regulatory pathways, and dedicated federal funding have supported paediatric medical device development more actively than in the EU; however, evidence and surveillance gaps persist. Both systems generate insufficient paediatric data, sustaining off-label use without robust evidence. Reform targeted to each system's shortcomings should prioritise proportionate evidence requirements, dedicated paediatric pathways, targeted funding, expert ethics oversight, and international data sharing to advance safe and equitable paediatric medical device access.