(2nd time this advice is posted, the first one posted the 12th January is not visible on the website. Please delete this one if this is duplicate) This proposition of extension solves partially the problem of bottleneck of certification requests by manufacturers. Notified Bodies are doing their best efforts to have adequate resources, but they lack trained human resources.
MC
MD101 Consulting
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
1
legislative file
of 583 tracked
1
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
MD101 Consulting filed 2 positions between 12 Jan 2023 and 13 Jan 2023, across 1 of the 583 legislative files tracked here, attaching a full position paper 1 time.
What they argued
This proposal doesn't solve the problem of software up-classification with the MDR. The current wording of Rule 11 in Annex VIII of the MDR places almost every SaMD in class IIa. This is confirmed by the MDCG 2019-11 and the Manual on Borderline and Classification V2 of December 2022.
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