Harmonizing Article 17 of the EU MDR: a Perspective on Overcoming Regulatory Fragmentation for Sustainable Perioperative Care
Federica Pirro*, Viola Vahle and Daniel Vukelich
ABSTRACT
Background: Healthcare systems across Europe face a dual challenge: reducing their environmental footprint while managing increasing patient care complexity and rising financial pressure. Third-party remanufacturing of single-use medical devices (SUDs) offers a circular economy solution to mitigate healthcare emissions, divert waste, and lower procurement costs. However, its implementation across the European Union remains constrained. Article 17 of the European Union Medical Device Regulation (MDR 2017/745) delegates regulatory oversight of remanufacturing to individual Member States, creating a fragmented landscape of conflicting national rules that impedes scalability of remanufacturing as sustainable clinical practice.
Methods: This Perspective article synthesizes current regulatory challenges and reflects upon two illustrative, contrasting perioperative experiences -in Ireland and Italy- to examine how national regulatory environments influence the feasibility of clinical sustainability initiatives.
Results: The contrast between the implemented initiative in Ireland and the aborted proposal in Italy suggests that national regulatory fragmentation creates substantial administrative and legal barriers for hospital systems attempting to implement sustainable and circular procurement practices.
Conclusion: Harmonizing remanufacturing regulations across Europe is essential to reduce greenhouse gas emissions from the health sector while managing the cost of care. An urgent revision of Article 17 is required to establish EU-wide harmonization and standardization, unlocking potential environmental and economic benefits for perioperative care across Europe.
