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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.

AmCham EU's consultation response in relation to the Consumer Agenda 2025-2030 calls on the Commission to streamline and harmonise consumer rules, accelerate digital product information, and provide clear EU-level guidance. Stronger action is also needed to protect consumers from counterfeit and unsafe goods while ensuring rules remain fair, future-proof and innovation-friendly.