On 16 March 2026, the European Commission hosted a conference in Brussels on “Medical Devices: Innovation and Patient Safety,” bringing together policymakers, regulators, and industry stakeholders to discuss the future of the EU regulatory framework. The event reflects ongoing efforts to balance innovation with strong patient safety standards under MDR and IVDR.
Discussions focused on improving the efficiency and predictability of conformity assessment processes while maintaining robust regulatory oversight. Particular attention was given to notified body capacity, the role of clinical evidence, and the need for clear and practical implementation of regulatory requirements, especially for emerging technologies.
The conference also followed the Commission’s December 2025 proposal to revise the current regulatory framework, highlighting a broader shift toward a more effective and innovation-friendly system. A key message throughout the event was that innovation and patient safety must evolve together, requiring both strong controls and streamlined pathways to market.
Overall, the discussions point toward continued refinement of the EU regulatory system, with a focus on improving access to safe, effective, and innovative medical devices while maintaining high standards of patient protection.
Source: https://health.ec.europa.eu/events/medical-devices-innovation-and-patient-safety-2026-03-16_en