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

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Τίτλος: Mapping the regulatory landscape for environmental sustainability of medical device practices within the European Union.
Συγγραφείς: Zarro M; Departmental Faculty of Engineering, University Campus Bio-Medico, Rome, Italy.; Department of Public Health and Infectious Diseases, 'Sapienza' University of Rome, Rome, Italy., Ferranti A; Departmental Faculty of Engineering, University Campus Bio-Medico, Rome, Italy., Garagozzo G; Life Supporting Technologies-LifeSTech, Universidad Politécnica de Madrid, Madrid, Spain., Fico G; Life Supporting Technologies-LifeSTech, Universidad Politécnica de Madrid, Madrid, Spain., Pecchia L; Departmental Faculty of Engineering, University Campus Bio-Medico, Rome, Italy.
Πηγή: European journal of public health [Eur J Public Health] 2026 Mar 14; Vol. 36 (2).
Τύπος έκδοσης: Journal Article
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Oxford University Press Country of Publication: England NLM ID: 9204966 Publication Model: Print Cited Medium: Internet ISSN: 1464-360X (Electronic) Linking ISSN: 11011262 NLM ISO Abbreviation: Eur J Public Health Subsets: MEDLINE
Imprint Name(s): Publication: Oxford : Oxford University Press
Original Publication: Stockholm, Sweden : Almqvist & Wiksell International, c1991-
Ιατρικοί όροι (MeSH): Equipment and Supplies*/standards , Conservation of Natural Resources*/legislation & jurisprudence , Medical Device Legislation* , Government Regulation*, Waste Management/legislation & jurisprudence ; European Union ; Humans
Περίληψη: 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.
(© The Author(s) 2026. Published by Oxford University Press on behalf of the European Public Health Association.)
Grant Information: Tech4GlobalHealth Observatory; Intesa Sanpaolo
Entry Date(s): Date Created: 20260122 Date Completed: 20260630 Latest Revision: 20260630
Update Code: 20260701
PubMed Central ID: PMC13064526
DOI: 10.1093/eurpub/ckaf262
PMID: 41570090
Βάση Δεδομένων: MEDLINE
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  Data: <searchLink fieldCode="AU" term="%22Zarro+M%22">Zarro M</searchLink>; Departmental Faculty of Engineering, University Campus Bio-Medico, Rome, Italy.; Department of Public Health and Infectious Diseases, 'Sapienza' University of Rome, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Ferranti+A%22">Ferranti A</searchLink>; Departmental Faculty of Engineering, University Campus Bio-Medico, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Garagozzo+G%22">Garagozzo G</searchLink>; Life Supporting Technologies-LifeSTech, Universidad Politécnica de Madrid, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Fico+G%22">Fico G</searchLink>; Life Supporting Technologies-LifeSTech, Universidad Politécnica de Madrid, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Pecchia+L%22">Pecchia L</searchLink>; Departmental Faculty of Engineering, University Campus Bio-Medico, Rome, Italy.
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  Data: 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.<br /> (© The Author(s) 2026. Published by Oxford University Press on behalf of the European Public Health Association.)
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