Subject: Feedback on the EU MDR/IVDR: problems for small businesses and system-wide delays To the European Commission, As a former notified body (NB) auditor, reviewer, and manager and current SME employee and consultant. I am writing to add my feedback on key problems with the MDR/IVDR rules.
DLS
Donlon Life Science Consulting Ltd
Company · Ireland
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 665 files tracked
2
legislative files
of 665 tracked
0
with a full position paper
attached to a submission
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Their record over time
Donlon Life Science Consulting Ltd filed 2 positions between 5 Oct 2025 and 14 Dec 2025, across 2 of the 665 legislative files tracked here.
What they argued
Positive news on set review timelines. I'm very disappointed that recertifications are still going to be a thing. Let the NB focus on new applications, surveillance, significant changes etc. A little confused also on information having to be provided to NBs on micro/small business status as, unlike in the US, there are no discounts being provided for SMEs apart from on a headcount only basis.
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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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