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

Abstract

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, understand