The proposed measures to simplify the MDR are, in principle, welcome, particularly where they aim to improve efficiency and reduce unnecessary administrative burden. However, their implementation raises significant concerns regarding fairness and competitive balance between manufacturers.
LCS
Company · France
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
LCS filed 2 positions between 2 Oct 2025 and 12 Feb 2026, across 1 of the 326 legislative files tracked here.
What they argued
As an SME manufacturing an older medical device, we face significant challenges with the implementation of the MDR. 1. Costs and administrative burden The costs of MDR certification are exorbitant, particularly for SMEs.
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