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Future of the European Health Union, MedTech Europe advocates for innovation and competitiveness

21 June 2024

Posted on 21.06.2024

Today, the Council of the European Union adopted its conclusions on the Future of the European Health Union, emphasising critical areas such as availability of medical technologies, digitalisation of health, and building more resilient health systems. MedTech Europe calls on Member States to enact policies that support the competitiveness and innovation capacity of the industry to ensure continued and timely access to innovative medical technologies for patients across Europe.

MedTech Europe welcomes the Council’s acknowledgement of the significant challenges related to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (MDR, IVDR). To improve the security of supply for and access to medical devices and in vitro diagnostic medical devices for patients and health systems, it is essential that all the structural deficiencies in the MDR and IVDR are identified and tackled. The conclusions have highlighted several such areas, including governance, innovation, costs, resource and expertise requirements, the particular impact for small- and medium-sized enterprises (SMEs), as well as orphan and pediatric devices.

Member States now need to act swiftly to acknowledge the need for comprehensive and cohesive reform of the regulations, with a clear mandate to the European Commission to provide a proposal by end of 2025 upon the conclusion of their Targeted Evaluation.

The Council conclusions also recognise the pivotal role of digital technologies, AI and health data in enhancing patient care, advancing research, and shaping public health policy. Digital policy has been evolving rapidly in the last five years, necessitating a period of adjustment for companies to fully comply with new EU regulations. To ensure smooth implementation, harmonisation in application between Member States and clear guidance on overlapping requirements will be essential. As we move into the next phase when the new requirements start applying to medical technologies, we stress the importance of wide inclusion of all healthcare ecosystem stakeholders in their implementation.

Building resilient health systems requires a robust, competitive, and innovation-driven industry. While EU regulations promote stability, trust and access to the world’s second-largest medical technology market, they have also raised barriers to entry and present risks of over-regulation. It is critical to adjust the regulatory environment so that it fosters innovation and supports manufacturers of any size, including SMEs, which are crucial for fostering a resilient and dynamic health sector. MedTech Europe hopes to work closely with Member States to find solutions that harmonise the current system and maintain Europe’s competitiveness and attractiveness for innovation to serve patients and health systems in Europe.

Setting the direction for EU health policy over the next five years, Member States now need to be ambitious in implementing their conclusions. Now is the time to make our health systems more patient-centric, digitally advanced, resilient and sustainable.

About MedTech Europe

MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices, and digital health. Our members are national, European, and multinational companies as well as a network of national medical technology associations who research, develop, manufacture, distribute, and supply health-related technologies, services, and solutions.

For more information, please contact:

Miriam D’Ambrosio
Senior Manager Communications
MedTech Europe
[email protected]