We strongly support the Targeted Revision of Regulation (EU) 2017/745 (MDR) and urge its swift adoption. The revision is a necessary and urgently needed corrective measure. With the long time of certification assessments, there would be a critical certification bottleneck from 2027, delays in enacting these reforms risk to face again the lack of MDR devices in the market with jeopardising patient access to safe and…
Farmac Zabban Spa
Company · Italy
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
Farmac Zabban Spa filed 2 positions between 6 Oct 2025 and 1 Jun 2026, across 1 of the 326 legislative files tracked here, attaching a full position paper 1 time.
What they argued
We are a company that produces and markets medical devices. In our opinion, the MDR imposes excessive bureaucratic burdens and a waste of resources. The assessment procedures are overregulated. We believe it does not add safety and quality compared to the MDD 93/42.
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