Side by side
Consultation participation and their own register declarations, side by side. Counts, not judgments — participation is not influence.
Counts here are a floor, never a total: they cover the 583 consultation files tracked so far (42,224 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.
Company · France
Industry association · Belgium
Declared costs: €6M+ a year · in the register since 2009
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 legislation · Transitional provisions for certain medical devices and in vitro diagnostic medical devices
Register facts self-declared (snapshot 2 Sept 2026); cost bands are floors. Shared files are shared attention, not evidence of coordination.
Their opening passages on the files they share, verbatim and in filing order. We do not summarize, compare, or characterize positions — read them at source.
SOPHYSA · filed 6 Oct 2025 · source
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.
EFPIA · filed 6 Oct 2025 · source
EFPIA welcomes the European Commissions call for evidence gathering input to address the identified problems highlighted in the MDR-IVDR targeted evaluation of March 2025 and is providing input related to drug-device/diagnostic used together (combined products) during clinical development and life cycle.
EFPIA · filed 16 Jul 2026 · source
EFPIA fully supports the aim of the targeted revision for the MDR/IVDR to simplify and streamline the current regulatory framework. However, the proposal misses the opportunity to enhance the current system even further. On the governance process, EFPIA supports a greater coordination role taken by the EMA as well as expansion of expert panels remits.
SOPHYSA · filed 17 Jan 2023 · source
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…
EFPIA · filed 18 Jan 2023 · source
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. EFPIA appreciates the opportunity to provide comments on the Proposal for an Extension of the Transitional Provisions for Certain Medical Devices and In Vitro Diagnostic Medical Devices (IVDs), issued on 6 January 2023.
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