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PROTHEOS INDUSTRIE

Company · France

2
positions filed
in the 326 files tracked
2
legislative files
of 326 tracked
0
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

PROTHEOS INDUSTRIE filed 2 positions between 4 Jul 2025 and 21 Apr 2026, across 2 of the 326 legislative files tracked here.

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 21 Apr 2026source

Clinical evaluation with proportionate risk assessment - In Expert Opinion CECP-2022-000232, one recommendation was to conduct an evaluation of all implants and combinaisons of a complex orthopaedic joint replacement system. It should be understood that all implant versions for all intended combinaisons in all claimed indications must have specific clinical data.

Revision of the Standardisation Regulationfiled 4 Jul 2025source

In the New Approach to CE marking, for areas where European standardisation is a regulatory requirement (e.g. for medical devices, see various decisions of the European Court of Justice where a harmonised European standard is valid as proof of conformity and thus serves as a legislative framework), the EU must make available such harmonised European standards.

Filed in French · English published by the European Commission

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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.

Showing 5 of 9.

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Everything on this page comes from PROTHEOS INDUSTRIE’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 If something is wrong or out of date, email info@policyspeak.com and we will correct it.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.