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 · Belgium
Declared costs: €1.5M+ a year · in the register since 2016
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.
MedTech Europe · filed 18 Jan 2023 · source
MedTech Europe takes note of the European Commissions proposal to amend the transitional measures in the Medical Devices Regulation (EU) 2017/745 and welcomes its recognition of the ongoing urgent risks of medical device shortages in Europe stemming from the Regulation 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.
MedTech Europe · filed 23 Jan 2026 · source
MedTech Europe welcomes the draft Implementing Regulation on MDR/IVDR Annex VII and broadly supports the direction taken. The text introduces important operational provisions which will bring urgently needed predictability, transparency and consistency to the conformity assessment of devices under MDR and IVDR.
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