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
NGO · Germany
Declared costs: not declared · in the register since 2008
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.
Deutsche Sozialversicherung Europavertretung · filed 2 Oct 2025 · source
Targeted legislative adjustments can be useful in achieving the objectives of the MDR and IVDR, also in view of the considerable difficulties manufacturers and notified bodies faced during the transition from the previous legal framework.
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.
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…
Deutsche Sozialversicherung Europavertretung · filed 17 Jan 2023 · source
On 6 January, the European Commission presented a proposal to amend the Medical Devices Regulation (MDR). The proposal extends the transitional period for adaptation to the new certification rules under the MDR. In doing so, the European Commission responds to the ongoing debate on the threat of shortages of urgently needed medical devices.
Filed in German · English published by the European Commission
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