Abstract
The proposal develops a conceptual framework explaining how AI‑enabled Digital Product Passports (DPPs) can serve as regulatory governance tools to manage high‑risk medical devices safely and sustainably across their lifecycle. High‑risk devices are framed as safety‑critical information environments where current practices are constrained by fragmented lifecycle visibility, siloed maintenance and regulatory data, and weak feedback loops between design, use and end‑of‑life, creating significant information‑processing gaps for regulators, manufacturers and healthcare providers. The study argues that AI‑enabled DPPs, as persistent, product‑centric data objects, can enhance information‑processing capacity by integrating provenance, composition, condition, performance, and environmental data, enriched with AI‑derived indicators such as failure risk, remaining useful life and environmental impacts.
Anchored in Information Processing Theory (IPT) and complemented by risk‑based regulatory governance and socio‑technical/circular economy perspectives, the framework conceptualises DPPs as inter‑organisational information infrastructures that reduce uncertainty and coordination failures across regulatory, organisational and supply‑chain levels. A structured synthesis of four literatures, DPPs and circular economy, predictive maintenance for medical equipment, regulatory governance and AI regulation, and sustainability in healthcare operations, feeds abductive theory building to specify key constructs (DPP capabilities, governance mechanisms, organisational capabilities and socio‑technical practices, and lifecycle outcomes). Theory‑driven scenarios (for example, repair‑versus‑replace decisions and risk‑ and sustainability‑based inspection regimes) will illustrate how DPP‑mediated data and AI analytics could be embedded into regulatory and organisational routines to enable risk‑proportionate oversight, predictive maintenance, circular practices such as repair, refurbishment and responsible end‑of‑life management, and improvements in traceability, compliance and environmental performance. Overall, the study aims to extend DPP and circular economy scholarship in safety‑critical healthcare by offering a multilevel governance‑oriented framework and a blueprint for aligning medical device regulation, AI, and sustainable procurement.