BVMed supports reinforcing the primacy of the Medical Devices Regulation (MDR) as the applicable sectoral legislation for AI medical devices under a sector-first approach within the AI Act framework, ensuring legal clarity and avoiding duplicative horizontal obligations. For further details please see position paper attached.
BBM
BVMed - Bundesverband Medizintechnologie e.V.
Industry association · Germany
2
positions filed
in the 639 files tracked
1
legislative file
of 639 tracked
2
with a full position paper
attached to a submission
Counts here are a floor, never a total: they cover the 639 consultation files tracked so far (53,766 submissions, mostly 2021–26), so an organization's real filing history is larger, not smaller.
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Their record over time
BVMed - Bundesverband Medizintechnologie e.V. filed 2 positions between 14 Oct 2025 and 12 Mar 2026, across 1 of the 639 legislative files tracked here, attaching a full position paper 2 times.
2025 · 1 filed2026 · 1 filed
What they argued
BVMed supports the EUs digital agenda and the Commissions ambition to promote innovation that benefits patients and healthcare systems, while emphasising the need to simplify and streamline existing legislation to strengthen Europes competitiveness. Medical technologies already operate under the robust MDR framework, which provides comprehensive requirements for safety, performance, and conformity assessment.
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