The Technology Council for Advanced Materials identified the health sector as a fifth focus area for advanced materials, recognising opportunities for these materials to contribute to safe-and-sustainable-by-design devices and cost-effective, enhanced patient outcomes. The forthcoming Advanced Materials Act, expected in late 2026, will create an EU (European Union) framework that impacts all sectors—including medical devices—making it crucial for stakeholders to stay engaged as regulatory proposals evolve.

Focus on Advanced Materials in the EU’s future Healthcare sector

In June 2025, the Technology Council for Advanced Materials identified health as a fifth strategic focus area for advanced materials, alongside energy, mobility, construction and electronics. This highlights the importance of advanced materials in improving the quality, efficacy and safety of medical devices, diagnostics, and therapeutic solutions for European citizens. The Council’s conclusions follow discussions from an earlier meeting in April 2025, where members explored the opportunities arising from the growing use of advanced materials in medical devices. In this context, stakeholders should be prepared to provide timely feedback on the EU’s upcoming Advanced Material Act.

Technology Council for Advanced Materials

The Technology Council for Advanced Materials, established in 2024, brings together representatives from the EU Member States, academia, industry, and other key players in research and innovation. Its purpose is to promote dialogue and collaboration, identify strategic goals and prioritise investments in research and innovation. During their meeting in April 2025, the Council discussed various opportunities ranging from enhancing the performance and safety of medical devices and enabling personalised treatments to enhancing Europe’s strategic supply chain autonomy and boosting Europe’s position in the global medical device market. In addition, these materials will contribute to the development of safe-and-sustainable-by-design (SSbD) materials that support environmental goals, while improving patient outcomes cost-effectively.

Advanced Materials and medical devices

Medical devices include any instrument, apparatus, implant, material or other article intended to be used for human beings for specific medical purposes. Advanced materials are increasingly integrated into these devices. For example, multifunctional materials and coatings that are biocompatible and antimicrobial can minimise adverse reactions to implants and optimise the performance of minimally invasive surgical robotics, thereby improving patient outcomes. Other examples include scaffolds that enable more effective regenerative medicine and wearable sensors that empower patients to self-manage their health conditions. In vitro diagnostic systems and in vivo imaging systems can also benefit from advanced materials.
To achieve these improvements, it is important to address several key issues in the research and development of advanced materials for the healthcare sector: digitalisation and artificial intelligence, scaling up and manufacturing, regulatory complexities and the need for patient involvement in the design and development process.

Advanced Materials Act

As advanced materials are expected to play a key role in supporting the EU’s goals for climate neutrality by 2050 and enhancing industrial competitiveness, the European Commission (EC) plans to issue an Advanced Materials Act to boost research, innovation, and manufacturing in this sector. A public call for evidence related to the planned act was completed in January. The proposal for this Act is expected by late 2026 and aims to establish a framework for developing and introducing innovative materials across various industries. This initiative will affect all sectors, including the medical devices sector. The impact assessment for the Advanced Materials Act will incorporate discussions and feedback from experts of the Technology Council for Advanced Materials.

Reflection by RIVM

The medical devices sector is highly regulated. Currently, the sector is understandably focusing on the targeted revision of the medical devices regulations, for which the European Commission has recently issued a proposal. This proposal aims to simplify EU rules for medical devices while ensuring the availability of safe, innovative devices to maintain high levels of patient safety, public health, and healthcare quality. Moreover, it seeks to enhance the competitiveness of the EU medical device sector, both in the internal market and globally.
At the same time, the sector is clearly aware of the implications of the Artificial Intelligence Act and other regulatory developments related to data and digital technologies. This awareness is reflected in the creation of a “frequently asked questions” document that addresses the interplay between this regulation and the medical devices regulations.
While the targeted revision proposal and the regulatory developments related to digital health are highly relevant, it is also essential for all actors in the medical devices sector to recognise developments in advanced materials. These materials will be crucial in addressing healthcare challenges and creating solutions to meet the growing demand for environmentally sustainable and circular materials, including for example the substitution of PFAS (Per- and polyfluoroalkyl substances).
The upcoming Advanced Materials Act, for which a proposal is planned for the fourth quarter of 2026, will be a horizontal act on advanced materials. Stakeholders should be aware that this act could significantly impact the sector, both by stimulating innovation and by potential interplay with the existing medical device regulations. They can also benefit from the research and innovation activities of the Technology Council for Advanced Materials.