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Regulatory Industry voices: Roche’s four pillars


“One of Roche’s sustainability priorities is reducing the environmental impact of our products across their life cycle. In diagnostics, we focus on four pillars – energy, water, material selection and circularity – to drive product sustainability improvements. Within the circularity pillar we aim to dematerialise our products. For example, our newest benchtop PCR instrument, the LightCycler Pro, is 5–25% lighter than its predecessor depending on configuration, which reduces material intensity. In logistics, we continuously optimise transport routes to lower emissions associated with distribution. In 2025, we reduced downstream transportation and distribution emissions by 23% compared with 2024, as disclosed in our 2025 Annual Report.” – Roche spokesperson


to cure. Based in Belgium, it commissioned a 2025 report to Boston Consulting Group titled ‘Decarbonising Healthcare: How a Competitive Medtech Industry Can Contribute’. The study found renewable energy and heat represent the most important short-term decarbonisation lever, with a 40% emission reduction potential, followed by circular economy-related levers longer term. “Circular-economy-related levers matter, however, [they] face significant regulatory and other barriers today, including fragmentation in the EU internal market, a lack of harmonised definitions and methodologies or slow uptake of value-based procurement,” Sigrid Linher, director of sustainability and environment at MedTech Europe, reveals. “To tap the circularity lever at scale, such barriers would have to be removed.


“Depending on their individual product portfolio, concrete Green Deal actions of medtech companies can take many different forms,” advises Linher. “These include green energy purchases, engaging in collective green electricity purchasing programmes and supply chain programmes to reduce carbon emissions in the value chain. “As regards products, longevity and remanufacturing are a long-standing practice for key applications, such as pacemakers or MRIs. “Further best practice examples include switching from on-site natural gas heating to CO2


-neutral


district heating, using less energy while scanning more patients per day, piloting take-back programmes for their single-use products or offering company-specific recycling programmes or zero- landfill commitments. Besides, the sector invests in innovative packaging solutions, and continuously researches and tests sustainable materials. The ESPR potentially includes certain medical technologies within its scope where product groups are later designated; however, no medtech-specific ecodesign requirements have yet been established.


The current situation


Some changes can improve things for manufacturers. However, Linher warns, some have also faced “additional administrative requirements and short-term transition costs”.


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“Globally harmonised standards and methodologies would facilitate the operationalisation of any green requirements.”


Regarding the end-of-life stage of life-cycle stewardship, the medtech industry is subject to extended producer responsibility obligations under harmonised EU waste directives covering electrical and electronic equipment (WEEE), packaging and batteries.


Circular economy design potentials and constraints remain closely linked to maintaining the legally required highest standards of patient safety. Linher feels that health and sustainability are now increasingly interlinked.


“The medtech industry is an innovation powerhouse, has always stood at the frontier of possibility, turning science into healing, and innovation into hope. Now, we’re called to this new frontier: to contribute our share to the decarbonisation of healthcare.”


Next steps MedTech Europe plans to maintain engagement in implementing the decarbonisation roadmap that it set out in its recent report. It feels that achieving meaningful emissions reductions depends on strong system-wide collaboration, as only 5–10% of the sector’s total carbon footprint is under direct control of medtech companies. It also sees the biggest potential for impact in addressing ‘Scope 3’ emissions. In 2026, implementation of ESPR-related sustainability requirements for intermediate materials such as steel and aluminium is expected to advance, following preparatory work begun in 2025. “Such requirements can have knock-on effects on medtech manufacturers. Besides, new EU rules on sustainable packaging and batteries will have to be implemented,” says Linher.


“Patient safety remains the North Star. The ESPR explicitly recognises the importance of protecting patient health and safety when implementing the new regulatory framework.


“Circular practices and design changes must always comply with stringent patient safety requirements. Rigorous testing and quality assurance should demonstrate that both safety and performance are fully maintained.”


Linher thinks system collaboration will be the “game-changer”. But medtech’s diversity could bring challenges.


Availability of over two million technologies to serve patients means there is no place for a ‘one size fits all’ approach to sustainability, Linher advises. Instead, it’s imperative to tailor solutions that reflect different use cases. It’s also important to cut through to end users, reminding them that health is an investment, not a cost, and sustainability and patient care can go hand in hand.


www.medicaldevice-developments.com


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