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The Medical Devices and In Vitro Diagnostics Regulations (MDR/IVDR) have created unworkable complexity for the medical devices industry, with dire consequences for European patients. To address these challenges, Members of the European Parliament (MEPs) or political groups can help address the unintended consequences of the current framework by tabling a Parliamentary Question that urges the European Commission to introduce targeted relief measures in parallel to a comprehensive revision of the MDR and IVDR. This would support the European Commission to implement short-term relief measures, in addition to the MDR/IVDR revision, that bolster efficiency, mitigate administrative bottlenecks and increase predictability in the regulatory processes. This would have an immediate impact on patient access and boost Europe’s innovation.

On Monday, 27 October, AmCham EU met with Lorena Boix-Alonso, Deputy Director-General, Directorate-General for Health and Food Safety, European Commission, for an exchange on the role of health policy in strengthening the EU’s competitiveness. The discussion focused on how to foster innovation while ensuring patient safety, as well as ways to streamline the legislative framework to improve efficiency and uphold high standards of care. AmCham EU highlighted the importance of evidence-based, future-proof regulation that supports a resilient health system and drives innovation. Continued dialogue is essential to advancing shared goals for Europe’s health agenda. 

From Tuesday, 7 to Wednesday, 8 October, AmCham EU travelled to the European Parliament in Strasbourg, France to engage with MEPs on the future of EU health policy. In meetings with over a dozen policymakers, members underscored the importance of a competitive, innovation-driven life sciences sector that ensures timely patient access to medicines and technologies. The discussions also covered the General Pharmaceutical Legislation, the Medical Devices Regulation, the Critical Medicines Act and the upcoming Biotech Act. The delegation called for evidence-based, proportionate policies that promote regulatory coherence and support Europe’s global leadership in health innovation.