We strongly welcome the European Commissions initiative to carry out a targeted revision of the MDR and IVDR. From the perspective of a small and medium-sized enterprise (SME) operating in the IVD sector, the proposal sends an important signal that existing implementation challenges have been recognised and that structural improvements are being pursued.
Pfaff medical GmbH
Company · Germany
Counts here are a floor, never a total: they cover the 326 consultation files tracked so far (29,503 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.
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Their record over time
Pfaff medical GmbH filed 3 positions between 30 Sept 2025 and 23 Jan 2026, across 2 of the 326 legislative files tracked here.
What they argued
We warmly welcome the opportunity to provide feedback as part of this consultation process, even if we would like this opportunity to have been opened earlier, as many manufacturers have been struggling with the challenges of MDR/IVDR implementation for years.
Filed in German · English published by the European Commission
We strongly welcome the draft implementing regulation. It addresses key structural challenges in the current MDR/IVDR implementation and represents an important step forward, particularly for small and medium-sized enterprises (SMEs) and for manufacturers that will be required to work with a Notified Body for the first time.
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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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