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MedTechXperts LLC

Company · Switzerland

2
positions filed
in the 326 files tracked
1
legislative file
of 326 tracked
2
with a full position paper
attached to a submission

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

MedTechXperts LLC filed 2 positions between 6 Oct 2025 and 3 Aug 2026, across 1 of the 326 legislative files tracked here, attaching a full position paper 2 times.

2025 · 1 filed2026 · 1 filed

What they argued

Simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and support of the European Medicines Agency for the expert panels on medical devices and the list of Union harmonisation legislationfiled 3 Aug 2026PDFsource

Thank you for allowing us to comment on the proposed MDR Revision text. There are some great revisions which have been done to the MDR regulatory framework. Thank you. Here are my recommendations (also within attached PDF) based on my long-time working experience in medtech as technical file & clinical evaluation writer & evaluator, as RA/ QMS/ Clinical Affairs manager and as senior biomedical engineer working for…

Simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and support of the European Medicines Agency for the expert panels on medical devices and the list of Union harmonisation legislationfiled 6 Oct 2025PDFsource

Thank you for allowing stakeholders of different colors to comment on the MDR Revision. Here are the first recommendations with rest in PDF. (1) Increase the harmonization by recognizing and referring to existing internationally recognized institutions: - IMDRF i.e. align with guidance on Technical File (e.g.

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Everything on this page comes from MedTechXperts LLC’s own submissions to the European Commission — we have added nothing and interpreted nothing. If something is wrong or out of date, email info@policyspeak.com and we will correct it. If you are an individual named in a record, our privacy policy sets out your rights to correction, objection and removal.

Quotes are verbatim from submissions published by the European Commission, trimmed to their opening passage and never summarized by a model. Organizations only, never individuals. Reused under Commission Decision 2011/833/EU; the European Commission is not liable for this reuse.