Mapping the regulatory landscape for environmental sustainability of medical device practices within the European Union.

Regulatory frameworks that integrate environmental sustainability into the lifecycle of medical devices (MDs) are essential to ensure quality, safety, and effectiveness for patients while minimizing environmental impact. The Medical Device Regulation 2017/745/EC (MDR) establishes the core framework for MDs, but additional EU legislation addresses Ecodesign, sustainable packaging, financial incentives, and waste management. Although sustainability is not explicitly included in the MDR, understanding how complementary EU regulations contribute to the European Green Deal agenda is crucial to inform decisionmakers and guide future integration of sustainability principles into medical device governance. We employed a validated policy mapping methodology, derived from the scoping review approach and adapted to systematically identify and analyse regulatory documents from policy repositories rather than academic databases. This method has been previously applied in diverse policy domains, including health, education, and digital innovation. Findings were reported according to the PRISMA-ScR. Eight binding regulations that are either directly applicable or transferable to MDs in the European Union were identified. Together, they introduce requirements on Ecodesign, packaging, financial incentives, and waste management. These complement the MDR framework by embedding sustainability principles into various stages of the MD lifecycle, even though they are not explicitly mandated within the MDR itself. While environmental sustainability provisions remain absent from the MDR, complementary EU regulations create an emerging framework that supports systemic economic transformation in line with the European Green Deal. Future research should examine enforcement and practical implementation of this framework across Member States to assess its impact on medical device regulation and environmental performance.