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.
PI
PROTHEOS INDUSTRIE
Company · France
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
Counts here are a floor, never a total: they cover the 665 consultation files tracked so far (57,774 submissions, mostly 2021–26), 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 665 legislative files tracked here.
2025 · 1 filed2026 · 1 filed
What they argued
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.
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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.