The Ecodesign for Sustainable Products Regulation (ESPR) has been effective since 18 July 2024. It represents a groundbreaking transformation in the European Union’s approach to product sustainability. Replacing the Ecodesign Directive (2009/125/EC), the ESPR expands its predecessor’s scope and introduces robust sustainability requirements aimed at making environmentally friendly products the norm across the EU market.
Following on from our 5-minute guide that summarised the EU Green Deal and its key directives, and our articles on the CSRD and CSDDD, our topical article below explores the third of the three key directives underpinning the EU Green Deal that are most relevant to MedTech companies.
Read on as our Founder Jörg Dogwiler and Head of Regulatory Bruno Gretler delve into the ESPR’s features, implications, and challenges, and explore its broader context within the European Green Deal and Circular Economy Action Plan.
What directive does the ESPR replace?
The previous Ecodesign Directive primarily regulated energy efficiency for specific product categories, including household appliances and industrial equipment. By 2021, these regulations reduced energy consumption by 10%, saving EU consumers an estimated €120 billion in energy costs.
The ESPR builds on this legacy, extending its reach beyond energy-related products to cover the broadest possible range of goods, including textiles, construction materials, and medical devices. This expansion ensures that sustainability is integrated across the entire lifecycle of products.
What are the core features of the ESPR?
Enhanced ecodesign requirements
The ESPR introduces stringent ecodesign standards that prioritise durability, repairability, upgradability, and recyclability. Medical device manufacturers must ensure that products are easier to maintain, disassemble, and recycle, reducing waste and promoting circularity.
Many medical device companies are already embracing projects that align with these goals – from producing chairs made from insulin pens, to turning dry waste into fuel, to implementing take-back programs that give products a second life.
Digital Product Passport (DPP)
One of the ESPR’s most revolutionary elements is the Digital Product Passport (DPP). This digital tool offers comprehensive information about a product’s composition, sustainability, and environmental impact. Accessible to consumers, regulators, and supply chain actors, the DPP fosters transparency and informed decision-making. For the medical device industry, where proprietary components are commonplace, manufacturers will be challenged to balance the implementation of DPPs with data confidentiality and intellectual property protection.
Prohibition on destruction of unsold products
To combat waste, the ESPR bans the destruction of unsold consumer goods, such as textiles and electronics. Large companies face direct restrictions, while small and medium-sized enterprises (SMEs) are granted transitional periods. Medical devices are subject to exceptions where safety and legal constraints preclude reuse but nevertheless should consider reuse strategies where feasible.
What are the Implementing Acts under the ESPR?
Each regulated product group (29 as per the end of 2024) in the Ecodesign Directive has its own “implementing act,” a legal measure that makes the Ecodesign criteria mandatory.
Currently, the EU is working on developing implementing acts for new product groups and revising existing ones. These new acts will initially come into effect under the current Ecodesign Directive. However, once the ESPR takes effect, it will assume control of these acts and replace the current directive.
What’s the implementation timeline for ESPR?
How does the ESPR integrate with the EU Green Deal & Circular Economy Action Plan?
The ESPR is a cornerstone of the European Green Deal, which seeks to make the EU carbon-neutral by 2050. Supported by €1 trillion in funding, the Green Deal emphasises decoupling economic growth from resource consumption and advancing public health.
The Circular Economy Action Plan, a key component of the Green Deal, outlines strategies for reducing waste, empowering consumers, and promoting sustainable products. The ESPR operationalises these goals by making sustainability requirements legally binding across EU member states.
What other initiatives fall under the Circular Economy Action Plan?
What action should medical device manufacturers take?
Medical device manufacturers face unique challenges under the ESPR. Meeting ecodesign criteria while ensuring patient safety and compliance with the EU MDR is a delicate balance. For example, enhancing durability or recyclability must not compromise clinical performance (see section 19 of the ESPR regulation 2024/1781). Furthermore, the prohibition on destroying unsold products necessitates innovative approaches to handling surplus devices. But these challenges can be mitigated with proactivity and innovation:
Proactively adapt design
Manufacturers should integrate sustainability principles early in the design phase. For example, modular designs can facilitate repair and recycling, aligning with the ESPR’s goals while reducing costs.
Develop digital infrastructure
Implementing DPPs requires robust data collection and management systems. Investing in technologies that track material sourcing, production processes, and end-of-life management will streamline compliance.
Enhance supply chain collaboration
Manufacturers must work closely with suppliers to ensure adherence to ecodesign standards. Clear communication, audits, and support for suppliers are critical to achieving compliance.
Explore circular business models
Leasing, take-back programs, and refurbishment initiatives can enhance product circularity and reduce waste. These models also align with consumer demand for sustainable practices.
Seek out compliance support
Recognising the financial and operational burdens on SMEs, the European Commission provides support through guidelines, training, and funding. Member states have been encouraged to establish one-stop shop mechanisms to facilitate compliance, including staff training and access to financial resources.
In conclusion…
The ESPR represents a paradigm shift in the EU’s commitment to sustainability. By mandating comprehensive ecodesign requirements and fostering transparency through tools like the DPP, the regulation empowers consumers, drives innovation, and accelerates the transition to a circular economy.
For the medical device industry, compliance poses challenges but also offers opportunities to lead innovation in sustainable manufacturing. By embracing proactive strategies and leveraging collaborative frameworks, manufacturers can navigate this ambitious regulatory landscape and contribute to a greener, more resilient future.
Our MedTech experts are ready to help with your pressing questions or challenges related to the ESPR and medical devices – simply get in touch to start the conversation.
