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.
Other · 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 · Implementing rules regarding requirements to be met by notified bodies
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.
MD-EX · filed 13 Jan 2023 · source
Dear, First I want to thank you to permit to give our feedback. Below some questions/ comments : - Harmonization for qualification of product reviewer and recognition at European Level RDM 2017/745 Annex VII §3.2.5 Criteria for qualification of product reviewer is not sufficiently detailed in RDM 2017/745 and subject to the interpretation and not harmonization between NB regarding qualification.
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.
MD-EX · filed 21 Jan 2026 · source
I fully share the objective of this revision. It is indeed essential to adapt the regulatory framework in order to enable companies, particularly SMEs, to cope with requirements that can sometimes be disproportionate, with unpredictable timelines and an administrative burden that has become difficult to sustain.
SPECTARIS e.V. · filed 23 Jan 2026 · source
SPECTARIS expressly welcomes the draft Implementing Regulation for Annex VII to the MDR/IVDR and sees it as an important step towards further stabilising and strengthening the European regulatory framework for medical devices and in vitro diagnostic medical devices.
Filed in German · English published by the European Commission
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