As a French SME operating in the medical device sector, we welcome the European Commissions initiative to simplify and streamline the EU regulatory framework for medical devices. We urgently call for measures to reduce administrative burden, enhance predictability, and foster innovation and competitiveness, while maintaining the highest standards of patient safety.
SOPHYSA
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.
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Their record over time
SOPHYSA filed 2 positions between 17 Jan 2023 and 6 Oct 2025, across 2 of the 583 legislative files tracked here.
What they argued
This proposal is needed and is a good news,but 2 aspects need to be reviewed : Article 1(1), point (a), of the proposal extension of the validity of certificates : In some third parties' countries it is required to have certificates with valid dates it is critical for the business to have NB re-editing the Certificates with the extended dates Article 1(1), point (b), of the proposal extension of the transition…
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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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