Another remark to my comment of May 12, 2021: In MDCG 2018-1 Rev. 4 of April 2021 the definition of the Basic UDI-DI quotes: "It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item". This quote is also repeated on the newly installed UDI Helpdesk.
TMA
Thommen Medical AG
Company · Switzerland
not in the EU Transparency RegisterThis organization files on consultations without a register number, so its record here is built from its filings alone. Register facts — staff, costs, accreditations — are not available for it.
2
positions filed
in the 583 files tracked
1
legislative file
of 583 tracked
0
with a full position paper
attached to a submission
Counts here are a floor, never a total: they cover the 583 consultation files tracked so far (42,224 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.
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Their record over time
Thommen Medical AG filed 2 positions between 12 May 2021 and 19 May 2021, across 1 of the 583 legislative files tracked here.
What they argued
In article 6 (3) the Basic UDI-DI should be removed. It does not facilitate the search for the correct eIFU. On all labels the product must anyway be sufficiently identifiable, including name and model of the product and manufacturer's name, address and website. This should serve to find the corresponding eIFU.
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