Assessing the Potential of the Digital Product Passport in the Regulated Biomedical Sector

The Digital Product Passport (DPP) is a key instrument of the European Green Deal and Circular Economy Action Plan, aiming to enhance data traceability, product lifecycle management, and sustainability. While DPP initiatives are advancing in sectors like electronics and textiles, the biomedical field remains largely unexplored, despite its strict regulatory landscape and environmental impact. The paper investigates the potential added value of the DPP in the biomedical sector. Through a qualitative analysis of regulatory requirements and current traceability practices, possible synergies are identified with DPP objectives such as transparency, reuse, and structured lifecycle data. The main findings highlight points of convergence between DPP functionalities and the operational needs of medical devices. The study shows that the DPP could act as a strategic enabler for improving traceability and supporting lifecycle-wide data integration in this sector. It also lays the groundwork for future digital integration, particularly within existing quality and risk management infrastructures.