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.
PROTHEOS INDUSTRIE
Company · France
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.
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.
- Bitkom e.V. · 2 files in common
- MedTech Europe · 2 files in common
- APPLiA - Home Appliance Europe · 2 files in common
- EURAMET e.V. · 2 files in common
- Deutsche Sozialversicherung Europavertretung (DSV) · 2 files in common
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 If something is wrong or out of date, email info@policyspeak.com and we will correct it.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.