We strongly support this legislative proposal to amend the MDR and the IVDR. However, we would like to provide several comments. MDR art 120.3 d e) It is foreseeable that the number of certification applications that the NBs will receive until May 26, 2024 (that is to say in 15 months from now) will be extremely large.
NEX
nexialist
Company · France
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
2
legislative files
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
nexialist filed 2 positions between 25 May 2021 and 18 Jan 2023, across 2 of the 583 legislative files tracked here.
2021 · 1 filed2023 · 1 filed
What they argued
We welcome the initiative to revise Regulation 207/2012 in order to align it with the MDR (EU) 2017/745. We appreciate the opening of a public consultation on this matter. Our comment concerns the a priori exclusion of the devices covered by Annex XVI (see art 1) Indeed, many devices of Annex XVI fall within the application criteria as described in article 3 of the draft regulation.
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Turns up on the same files
Organizations that also filed on at least two of the same consultations. A shared interest in the same dossiers — not evidence of coordination, and we do not suggest any.
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