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Takeda Pharmaceuticals USA

Company · Ireland

2
positions filed
in the 326 files tracked
1
legislative file
of 326 tracked
2
with a full position paper
attached to a submission

Counts here are a floor, never a total: they cover the 326 consultation files tracked so far (29,503 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.

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Their record over time

Takeda Pharmaceuticals USA filed 2 positions between 6 Oct 2025 and 31 Jul 2026, across 1 of the 326 legislative files tracked here, attaching a full position paper 2 times.

2025 · 1 filed2026 · 1 filed

What they argued

Simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and support of the European Medicines Agency for the expert panels on medical devices and the list of Union harmonisation legislationfiled 31 Jul 2026PDFsource

Takeda Pharmaceuticals welcomes the opportunity to provide comments on the proposed changes to the medical device and in vitro diagnostic regulatory frameworks. Overall, we support measures that promote a more proportionate, risk-based, and harmonised regulatory system while maintaining robust standards for patient safety and device performance.

Simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and support of the European Medicines Agency for the expert panels on medical devices and the list of Union harmonisation legislationfiled 6 Oct 2025PDFsource

As both a medicinal product and medical device manufacturer, Takeda Pharmaceuticals welcomes the opportunity to provide evidence on specific challenges the MDR and IVDR have presented to pharmaceutical companies within the EU. Please find attached detailed information on the key challenges Takeda has encountered due to MDR and IVDR along with some proposed solutions to address these issues in the future.

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