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 · Germany
Declared costs: €25K+ a year · in the register since 2012
Transitional provisions for certain medical devices and in vitro diagnostic medical devices · Electronic instructions for use for 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.
nexialist · filed 18 Jan 2023 · source
We strongly support this legislative proposal to amend the MDR and the IVDR. However, we would like to provide several comments. MDR art 120.3 d e) It is foreseeable that the number of certification applications that the NBs will receive until May 26, 2024 (that is to say in 15 months from now) will be extremely large.
SPECTARIS e.V. · filed 18 Jan 2023 · source
At the EPSCO Health Council on December 9, 2022, the Commission had announced to put forward a TARGETED LEGISLATIVE PROPOSAL at the beginning of January 2023 TO ADDRESS the IMMINENT RISK OF SHORTAGES of MEDICAL DEVICES in Europe and the associated risk of a public health crisis, stemming from the Medical Device Regulation (MDR) implementation challenges.
nexialist · filed 25 May 2021 · source
We welcome the initiative to revise Regulation 207/2012 in order to align it with the MDR (EU) 2017/745. We appreciate the opening of a public consultation on this matter. Our comment concerns the a priori exclusion of the devices covered by Annex XVI (see art 1) Indeed, many devices of Annex XVI fall within the application criteria as described in article 3 of the draft regulation.
SPECTARIS e.V. · filed 25 May 2021 · source
SPECTARIS is the German Industry Association for Optics, Photonics, Analytical and Medical Technology based in Berlin. The association represents 400 predominantly medium-sized German companies. This initiative aims to renew the existing eIFU rules established under Commission Regulation (EU) 207/2012 in order to “reduce the environmental burden and reduce costs for the medical device industry while maintaining or…
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