Regulatory
Ready for
oncerns about the environment are nothing new. Visible across most elements of our lives, from the products the public uses to how we conduct our careers, many of these concerns have made their way to the forefront of our individual and collective priorities. But it’s in recent years that sustainability regulation has really ramped up. The Ecodesign for Sustainable Products Regulation (ESPR) formally entered into force in July 2024, following its adoption in April 2024. Since then, it’s served as the cornerstone of the European Commission’s approach to “more environmentally sustainable and circular products”. It came with a warning that products, and how they’re used, can significantly impact the environment, with consumption in the EU contributing towards climate change and pollution. After all, Europe is the fastest-warming continent. The Commission describes the ESPR as part of a wider package of measures underpinning the 2020 Circular Economy Action Plan and supporting the transition to a “circular, sustainable and competitive” economy. It aims to help the EU reach its environmental and climate goals, double its circularity rate of material use, and achieve its energy-efficiency targets by 2030. In 2025, the Commission published its first draft working plan under the ESPR, outlining
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www.medicaldevice-developments.com
the next phase?
From greening operations to life-cycle stewardship, end-of-life mandates and circular-economy design constraints, Ellie Philpotts speaks to Sigrid Linher, director of sustainability and environment at MedTech Europe, and RMIT University’s Pranay Kumar about how global firms can operationalise action across multi-jurisdictional supply chains while maintaining safety, performance and access to life-saving and life-sustaining medical technologies for patients.
priority product groups through 2030. Digital Product Passports remain in the pilot and standard-setting phase.
Meanwhile, the European Green Deal aims for Europe to become the first climate-neutral continent by 2050. Under the EU Climate Law, member states collectively must cut net greenhouse-gas emissions by at least 55% by 2030 compared with 1990 levels. These are all shifting environmental compliance within medtech from optional to formal product requirement. So, just past halfway into this critical decade, how are the changes working out so far?
Unveiling in Europe
Companies across the continent should be trying to adhere to the Commission’s action points. These are for them to: ■
assess whether their products are covered by the priority list for which the EU will develop ecodesign requirements over the next few years
■ ■
consider the indicative timelines for each priority product group
consider whether to provide input in the development of the ecodesign requirements; for instance, by participating in the Ecodesign Forum
MedTech Europe is the trade association representing this sector’s industries, from diagnosis
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