European healthcare is entering a new phase of transformation. The European Economic and Social Committee (EESC) has expressed its support for the European Commission’s proposal to modernise and simplify the EU’s regulatory framework for medical devices and in vitro diagnostic tools. This reform aims to reduce administrative burdens while ensuring that innovation and patient safety remain at the heart of medical progress.

The proposal amends Regulations (EU) 2017/745 and 2017/746, which govern medical devices and in vitro diagnostics, as well as Regulation (EU) 2022/123, strengthening the role of the European Medicines Agency (EMA) in supporting expert panels. It also updates Regulation (EU) 2024/1689, which aligns harmonisation legislation across the EU internal market.

These changes respond to long-standing challenges faced since the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) came into effect. Many small and medium-sized enterprises (SMEs) have struggled with complex certification requirements, extended timelines, and high costs — issues that have slowed innovation and created risks of device shortages.

The initiative, titled “Targeted revision of the EU rules for medical devices and in vitro diagnostics”, was proposed at the end of 2025 and represents a crucial step toward a more predictable, innovation-friendly healthcare environment. Its main objectives include:

• Reducing administrative and reporting burdens for manufacturers and healthcare institutions.
• Enhancing predictability and cost-efficiency in certification processes.
• Making conformity assessments proportionate to device risk levels.
• Encouraging digitalisation and closer international regulatory cooperation.

Together, these coordinated efforts give renewed hope for the future of medicine: a future where cutting-edge technologies, regulatory agility, and patient-centered innovation work hand in hand. As Europe strengthens its medical and digital ecosystems, the healthcare sector moves closer to a model that is both technologically advanced and accessible to all. These advancements align with ongoing innovation efforts across Europe, such as the Target Project, which leverages artificial intelligence and virtual twin models to enable personalised management of atrial fibrillation–related stroke and improve patient outcomes.

The EESC has underscored that simplification must not compromise transparency or patient safety. Instead, it calls for collaboration between manufacturers, healthcare professionals, and patients to ensure that innovation thrives responsibly and sustainably.

These policy steps, combined with pioneering research projects across Europe, represent a powerful shift toward smarter, safer, and more inclusive healthcare systems, proof that Europe is investing not just in medical devices, but in the future of human health itself.

For more information, visit the European Commission’s Medical Devices Sector page.