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EU Regulations for Sustainable Medical Devices

EU Regulations for Sustainable Medical Devices

Ecomedic Team

Feb 27, 2024

The European Union (EU) has been at the forefront of integrating sustainability into various sectors, including healthcare. The region's healthcare sector, responsible for a significant portion of global emissions, is undergoing transformative changes to meet new regulatory standards aimed at reducing its environmental footprint.

Emissions Targets and Sustainability Initiatives

Globally, the healthcare sector accounts for approximately 4.4% of net emissions, with a considerable portion arising from the supply chain, including the production and disposal of medical devices and pharmaceuticals. The EU's strategy to mitigate this involves enhancing sustainability across the board, from hospital operations to the lifecycle of medical devices​​. [1] (Healthcare: Medical Devices 2023 - Germany  | Global Practice Guides | Chambers and Partners, n.d.)

Regulations on Medical Devices

The EU has revamped its regulations concerning medical devices through the Medical Devices Regulation (MDR), aiming to improve device safety and effectiveness while also considering environmental impacts. This regulation, which updates previous directives, encompasses a broad range of devices and introduces stringent safety and quality standards​​. 

The healthcare sector faces unique challenges in its transition to sustainability, particularly concerning single-use medical items and the environmental impact of medical waste. The EU is addressing these challenges by promoting circular economy principles, which aim to design out waste and enhance the lifecycle of products through measures like refurbishment and repair. The proposal for a new EcoDesign for Sustainable Products Directive, featuring a "Digital Product Passport," is a step towards more sustainable healthcare by providing information on product sustainability and encouraging repairability. Despite the complexity of reducing packaging waste for single-use medical items, efforts are underway to find sustainable solutions, with the potential for significant advancements in polymer technologies in the coming years

National Perspectives in the European Union:


While directly targeting healthcare with regulations in the Climate Action Law remains in its early stages, its overarching framework sets the stage for future sector-specific policies impacting healthcare's carbon footprint. Adopted in 2021 and recently reformed in June 2023, the law mandates an ambitious 65% reduction in greenhouse gas emissions by 2030 compared to 1990 levels. It establishes an annual review process and assigns individual emission budgets to different sectors, paving the way for potential future regulations specifically targeting healthcare's emissions reduction contributions. Additionally, the law promotes cross-sectoral collaboration and encourages innovative solutions, which could indirectly benefit healthcare in transitioning towards more sustainable practices.

[2] (Germany’s Climate Action Programme 2023, 2023)


France's National Health and Environment Pact (Pacte National Santé-Environnement) tackles healthcare sustainability through a collaborative approach. Launched in 2020, it unites diverse stakeholders in achieving concrete goals:

  • Reduce energy consumption in healthcare facilities by 20% by 2025: Participating hospitals show promising progress, with initial electricity consumption reductions of 4-8% (source: [url pact national santé environnement ON Ministère des Solidarités et de la Santé (.gouv.fr) sante.gouv.fr])

  • Reduce healthcare waste by 15% by 2025: Studies indicate a 6% reduction in non-hazardous and a 3% reduction in hazardous waste generation in participating hospitals (source: 

  • Increase the share of green purchases in healthcare facilities to 50% by 2025: While data on achieving this specific target remains limited, participating hospitals demonstrate increased awareness and commitment to sustainable procurement.

[3] (Du Plan National Santé-Environnement, 2004)

The Danish Packaging Act acts as the backbone, mandating recycling and sorting of specific packaging types across all sectors, including healthcare. This incentivizes hospitals to choose more sustainable options to minimize associated fees and comply with regulations. Additionally, the ambitious Regions' Sustainability Strategy sets a target for 75% CO2 emission reduction by 2030, encouraging hospitals to consider the environmental impact of packaging during procurement. This has led to a shift towards less material-intensive or even reusable options. Furthermore, collaborative initiatives like Clean and Circular Healthcare bring industry players together to develop and implement innovative solutions for sustainable packaging in healthcare. This combined effort, while not directly legislated, is effectively pushing hospitals towards greener packaging choices, contributing to the overall goal of reduced carbon emissions.

[4] (Barsony, 2023)

Case Study: Green Giant in Action: Green Giant Transformed: Region Zealand Hospitals Lead in Sustainable Procurement

Denmark's Region Zealand hospitals aren't just green giants in energy efficiency; they're pioneering sustainable procurement within healthcare. While they've achieved a remarkable 78% reduction in CO2 emissions through energy innovations, their focus now shifts to Scope 3 emissions, particularly those embedded in medical devices, products, and services linked to clinical pathways.

Case Study: Beyond Energy Efficiency

Building on their success in energy efficiency, Region Zealand hospitals are tackling Scope 3 emissions through these key strategies:

  • Lifespan optimization and reprocessing: Extending the lifespan of medical devices through proper maintenance and reprocessing reduces the need for new equipment production, minimizing associated emissions. Studies show reprocessing certain devices can decrease CO2 emissions by up to 80% compared to purchasing new ones.

  • Sustainable product selection: Implementing stringent criteria for environmentally friendly materials and production processes in procured medical devices and products significantly reduces their embodied carbon footprint. A 2020 study found sustainable procurement in healthcare could save 2.8 million tonnes of CO2 in the UK alone. 

  • Circular economy principles: Embracing circular economy principles in clinical pathways involves minimizing waste, maximizing reuse and recycling of medical products, and exploring innovative solutions like product-as-a-service models. A Dutch study showed circular economy approaches in healthcare could lead to a 50% reduction in material use and associated emissions.

[5] (New North Zealand Hospital: A Resilient Acute Care Hospital for the Future, Hillerød, Denmark — English, n.d.)

Conclusion and Key Learnings

The EU's healthcare sector is undergoing significant changes to align with broader sustainability goals. Through updated regulations like the MDR, and national efforts in countries like Germany and France, the sector aims to reduce its environmental impact while ensuring high standards of patient care. The transition towards sustainability is complex, requiring a delicate balance between environmental, economic, and health-related considerations.

Region Zealand's journey offers valuable insights for other healthcare institutions:

  • Holistic Approach: Combining multiple strategies like energy efficiency, renewable energy, and sustainable procurement creates a synergistic effect for maximum impact.

  • Engaging Stakeholders: Active involvement of staff and patients fosters a culture of sustainability and drives behavioural change.

  • Continuous Improvement: Setting ambitious goals and regularly monitoring progress ensures sustained efforts and further emission reductions.


  1. Healthcare: Medical Devices 2023 - Germany  | Global Practice Guides | Chambers and Partners. (n.d.). 

  2. Germany’s climate action programme 2023. (2023, October 26). Clean Energy Wire. 

  3. Du Plan National Santé-Environnement, F. C. D. (2004, January 1). Plan national santé-environnement. La Documentation Française. 

  4. Barsony, T. (2023, December 5). EPR Denmark: Extended Producer Responsibility 2025. Ecosistant. 

  5. New North Zealand Hospital: A resilient acute care hospital for the future, Hillerød, Denmark — English. (n.d.). Climate-ADAPT. https://climate-adapt.eea.europa.eu/en/metadata/case-studies/new-north-zealand-hospital-a-resilient-acute-care-hospital-for-the-future-hillerod-denmark

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Built for hospitals & suppliers to reduce emissions now

100 mega tons Co2 equivalent every year

Our ambition at Ecomedic

Largest Healthtech Venture Builder in Europe

Innovation Arm of the NHS UK

Built for hospitals & suppliers to reduce emissions now

100 mega tons Co2 equivalent every year

Our ambition at Ecomedic

Largest Healthtech Venture Builder in Europe

Innovation Arm of the NHS UK