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.
Donlon Life Science Consulting Ltd
Company · Ireland
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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 326 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.
- MedTech Europe · 2 files in common
- EURAMET e.V. · 2 files in common
- TÜV-Verband e. V. · 2 files in common
- Cruelty Free Europe · 2 files in common
- Pharma Deutschland e.V. · 2 files in common
Showing 5 of 26.
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