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.
Advancing short-term improvements to the EU Medical Devices and In Vitro Diagnostic Regulations
Related items
Position Paper
7 Jul 2025
Critical Medicines Act: securing resilient and diversified supply chains for continuous access
Position Paper
25 May 2025
Consultation response: Revision of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations
Position Paper
27 Apr 2025
Proportionate approach to the REACH universal per- and polyfluoroalkyl substances restriction proposal
Policy priorities
Insights and advocacy driving Europe’s policy agenda. Our priorities support growth, innovation and a stronger transatlantic economy.
Membership
Connecting business and policymakers to strengthen the voice of American companies in Europe.