Environmental Impact

Introduction

The environmental impact of healthcare technologies, including medical devices, is increasingly under scrutiny from regulators, payers, and procurement bodies. With healthcare systems contributing significantly to national carbon footprints, there is mounting pressure to include sustainability assessments as part of Health Technology Assessment (HTA). For manufacturers, this marks a shift from traditional focus areas, such as clinical safety, efficacy, and cost-effectiveness, towards demonstrating how their devices impact the environment across their lifecycle.

In this article, we explore the current expectations regarding evidence of environmental impact in HTA for medical devices and outline the relevant regulations, frameworks, and standards that manufacturers should be aware of.

Why environmental impact matters in HTA

Traditionally, HTAs have focused on clinical and economic evidence to guide reimbursement and policy decisions. However, as health systems strive to meet carbon reduction targets and sustainability goals, HTA bodies are beginning to incorporate environmental considerations into their frameworks.

Several factors are driving this change:

• Policy Commitments: National health services such as the NHS (UK), which committed to net-zero carbon emissions by 2045, are embedding sustainability into procurement and reimbursement decisions.
• Public Accountability: Taxpayer-funded health systems are under pressure to make environmentally responsible choices.
• Lifecycle Emissions: Many medical devices contribute significantly to emissions through energy use, manufacturing, sterilisation, packaging, and end-of-life disposal.
• Waste Management: Medical waste is a significant challenge for health facilities.

Expanding access to healthcare globally is essential for improving health equity, but it also brings increased environmental pressures. As more people access medical technologies, medical device production, distribution, and disposal will increase, leading to higher energy consumption, greater use of raw materials, and more healthcare-related waste. This growth could significantly amplify the healthcare sector’s environmental footprint without proactive mitigation strategies, such as eco-design, sustainable procurement, and circular economy approaches. Balancing access with sustainability is therefore critical to ensure long-term health for both people and the planet.

What environmental evidence is expected?

Environmental evidence refers to any data or analysis that describes a product’s environmental burden across its lifecycle. For medical devices, this could include:

• Greenhouse gas (GHG) emissions (including CO₂ equivalents)
• Water use
• Waste generation (including hazardous waste)
• Energy consumption
• Material composition (e.g., plastics, rare metals, conflict minerals)
• Recyclability and end-of-life options
• Environmental toxicity or pollutants

HTA bodies may request this information to compare alternatives in terms of sustainability or to assess whether a novel device provides an environmental advantage.

Frameworks and regulations influencing environmental evidence

Emerging tools and guidelines

EUnetHTA 21 and Environmental Impact

The European Network for HTA (EUnetHTA) has acknowledged environmental impact as a relevant non-clinical domain. Under EUnetHTA 21 (the successor to EUnetHTA Joint Actions), environmental aspects may be included in joint clinical assessments or contextual domains.

Though detailed methodologies are still under development, manufacturers should begin collecting baseline data aligned with international LCA standards.

Green HTA Working Groups

Several national bodies are developing methodologies and guidance on “Green HTA,” including:

• HAS (France): Considering eco-design and circular economy principles in device evaluation.
• IQWiG (Germany): Piloting approaches for integrating sustainability into cost-benefit assessments.
• Canada’s Drug Sgency (Canada): Exploring how environmental criteria could be applied in comparative effectiveness research.

Best practices for medical device manufacturers

• Design for Sustainability: When designing medical devices or IVDs for sustainability, prioritise strategies that minimise environmental impact without compromising safety or performance. Focus on reducing packaging and eliminating unnecessary components to cut waste and lower resource use. Select renewable or biocompatible materials where feasible, supporting patient safety and environmental responsibility. Additionally, ensure your design enables easy disassembly and recycling at the end of the product’s life, helping to close the loop and meet growing regulatory and customer expectations for eco-friendly solutions.

• Conduct a life cycle assessment (LCA) early: To maximise the value of an environmental assessment, it’s essential to conduct a life cycle assessment (LCA) early, ideally during product development, so that environmental impact insights can inform design decisions. Aligning your LCA with recognised standards such as ISO 14040/14044 ensures credibility and consistency. Focus on comparative assessments — for example, weighing the environmental trade-offs between reusable and disposable devices — but be mindful that achieving true comparability can be challenging, as devices serving similar clinical purposes may have very different material compositions or energy demands. A common pitfall, particularly for smaller manufacturers, is data gaps in supply chain information, especially upstream; engaging suppliers early and exploring sectoral databases can help fill these gaps and strengthen your LCA.

• Track and Report Carbon Footprints: To effectively track and report carbon footprints, use recognised frameworks such as the GHG Protocol or ISO 14067, which provide clear methodologies for calculating and disclosing emissions. A good practice is to quantify emissions across all relevant life cycle stages — covering direct emissions (Scope 1), purchased energy (Scope 2), and indirect value chain emissions (Scope 3) — to ensure a comprehensive and credible carbon footprint report.

• Substantiate Environmental Claims: When making environmental claims for a medical device or IVD, such as describing a product as “eco-friendly” or “low-waste”, it’s essential to back these statements with robust, verifiable data. Unsupported claims risk accusations of greenwashing, which can damage credibility with regulators, customers, and payers. To avoid this, ensure all marketing materials and regulatory submissions are supported by evidence such as a life cycle assessment (LCA) that transparently demonstrates the environmental impact across the product’s lifecycle.

• Engage with Procurement Teams: To successfully engage with procurement teams, it is important to provide environmental product declarations (EPDs) and clearly demonstrate how your device aligns with the institution’s carbon reduction or sustainability goals. While environmental assessment is not yet a strict regulatory requirement, it is becoming increasingly influential in HTA processes and procurement decisions, particularly for public-sector tenders and large healthcare systems. A key tip is to quantify environmental benefits wherever possible, as some sustainable devices may have higher upfront costs that could challenge their value-for-money case unless the long-term environmental and operational advantages are clearly presented. Invest in environmental certifications (such as ISO 14001, ISO 13485 with sustainability add-ons, Energy Star or equivalent for powered devices) to prove your environmental commitments.

Conclusion

As environmental impact becomes an integral part of healthcare decision-making, manufacturers must adapt to provide clear, credible evidence of their devices’ sustainability. Health Technology Assessment is evolving to include environmental performance alongside clinical and economic outcomes.

By aligning with international standards such as ISO 14040/44, engaging with lifecycle thinking, and integrating eco-design principles early in development, manufacturers can position their products for success in an increasingly green-conscious HTA landscape.

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