Medtech sector faces new EU 'green deal' recommendations

MedTech Europe is championing a greener future, following the recent industry push for greener and digitalised medical devices and in vitro diagnostics that featured prominently in the European Commission's report on the future of European competitiveness.

The leading European association representing the interests of the medical technology sector has recently issued comprehensive recommendations that are poised to help health tech businesses reach significant environmental milestones, in line with EU law requirements.

This initiative aligns seamlessly with the broader ambitions of the European Union's Green Deal Industrial Plan, which seeks to transform the EU into a modern, resource-efficient and competitive economy.

Greener and more sustainable medtech

The recommendations from MedTech Europe are designed to address the pressing need for sustainable, equitable and climate-resilient healthcare systems. They come in the wake of the Commission's sustainable prosperity and competitiveness plan, which aims to integrate sustainability across all sectors, including healthcare. The recommendations tackle various barriers to achieving these goals, such as fragmented regulatory frameworks, inconsistent definitions and standards, and financial and technological limitations.

EU medtech regulations and sustainability

Implementing the EU Green Deal in healthcare requires a solid grasp of the current legislative and regulatory landscape for medical devices. Central to this are the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). A recent European Parliament's proposed review of these regulations promises significant changes and much-needed relief for the industry if it becomes law.

MedTech Europe's recommendations emphasise the need for better consistency between these sector-specific regulations and broader environmental legislation. For instance, the transition to sustainable substances and materials should align with the MDR and IVDR requirements to ensure that patient safety and product efficacy are not compromised.

Furthermore, substance restrictions in validated medical devices or diagnostics should apply only to new products, allowing smooth transitions aligned with development cycles.

The recommendations also propose realistic transition pathways that would allow sufficient time for manufacturers to adapt to new regulatory requirements without disrupting the supply of essential medical technologies. Potential derogations should cover manufacturing, imports, and supply chains, ensuring continued access to essential medical technologies when no alternatives exist.

Interplay with other regulatory frameworks

Beyond the MDR and IVDR, the implementation of the EU Green Deal in medtech intersects with several other legislative and regulatory frameworks and instruments. These include the new EU batteries regulations, the recent eco-design for sustainable products regulation, the EU chemicals strategy for sustainability and the array of EU chemicals regulations, the EU's circular economy action plan and many more. MedTech Europe's recommendations underscore the need for coherence between these frameworks to avoid duplication and unnecessary burdens on the medical technology industry.

For example, the EU chemicals strategy for sustainability aims to boost innovation for chemicals that are safe and sustainable by design. However, the medical technology sector faces unique challenges in finding and implementing safer alternatives that meet the stringent safety and performance requirements of the MDR and IVDR. To address this, the recommendations suggest a streamlined and harmonised approach to chemical assessments to ensure that the transition to sustainable substances does not compromise patient safety or product efficacy.

Similarly, the EU circular economy action plan promotes the use of recycled materials and the development of circular business models. MedTech Europe's recommendations highlight the need for aligned definitions and standards for circularity, as well as the removal of regulatory barriers that hinder the reuse, refurbishment, and recycling of medical devices.

Sustainability recommendations

MedTech Europe's guidance is comprehensive and multifaceted. It spans various aspects of sustainability from renewable energy and circular economy to digital transformation and sustainable financing. The recommendations aim to create a supportive environment that enables the rapid transition, deployment, and scaling of sustainable solutions in healthcare.

Accelerating the roll-out of renewable energies and transitioning towards smart clean energy infrastructures are among the core tips provided to EU medical technology businesses. Continuous access to renewable energies and heating at affordable prices is essential for decarbonising healthcare, including the medical technology sector.

MedTech Europe also advocates for a sustainable financing framework to support research and innovation in the development and use of alternative materials, circular products and digital solutions. The recommendations call for the earmarking of funding and the unlocking of financing for the green transition of the medical technology sector under several EU initiatives.

AI solutions for efficiency

Another critical point is to leverage the transformational synergies of the green and digital agendas. Digital tools and software can enhance diagnosis and treatment while reducing the need for physical resources, thereby supporting the shift from resource-intensive clinical facilities to networked lower-cost settings and the home.

Artificial Intelligence (AI) has the potential to significantly enhance efficiency and sustainability across a wide range of life sciences and healthcare systems and applications that aim at improving workflow management in hospitals, reducing energy consumption for certain procedures, and enabling remote monitoring and telemedicine. These digital tools can reduce the need for physical resources and patient travel, thereby lowering the overall carbon footprint of healthcare services.

However, the development and use of AI also generate emissions, and the global carbon footprint of the tech sector is expected to rise significantly in the coming years, MedTech Europe warns.

To mitigate this, the recommendations advocate for the adoption of "green software" practices. Examples of practices listed in the recommendations include the development of sustainable AI solutions with more resource-efficient programming languages. The recommendations further urge the development of standards and tools in support of this approach, which does not only champion the green transition but also ensure that digital health solutions contribute to the overall sustainability goals of the EU Green Deal.

Osborne Clarke comment

MedTech Europe's recommendations for the EU Green Deal in Healthcare offer a blueprint for integrating sustainability into operations from product design and manufacturing to supply chain management and financing. By following them, businesses can boost their competitiveness, drive innovation, and support the broader goals of the EU Green Deal.

For manufacturers, the EU industry association provides a draft roadmap for embedding sustainability into product design, production processes and supply chains.                                                                                                       This includes adopting circular practices like using fewer materials, preserving material value during manufacturing and introducing innovative business models that promote material efficiency. Collaboration with suppliers, healthcare providers and other stakeholders is also key to addressing carbon emissions and enhancing environmental sustainability throughout the lifecycle of medical technologies.

Distributors and suppliers also play a crucial role in the shift to sustainable healthcare systems. The recommendations call for removing regulatory and policy barriers that hinder the reuse, refurbishment and recycling of medical devices, and for developing harmonised metrics to measure circularity and environmental performance. By aligning with these recommendations, operators can contribute to the healthcare sector's sustainability goals while enhancing their market competitiveness.

The recommendations also highlight the importance of sustainable financing and investment in research and innovation. Medical technology businesses can tap into EU funding and investment support to develop and scale sustainable solutions, such as alternative materials, circular products and digital health technologies. Leveraging these opportunities can drive innovation, improve patient outcomes and support the EU Green Deal's broader objectives.

Medical devices and diagnostics businesses are encouraged to consider these guidelines and take proactive steps to integrate sustainability into their operations. Doing so will help them meet regulatory requirements and position themselves as leaders in the transition to sustainable healthcare systems.