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
Company · Germany
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.
MeTeCo - MedizinTechnikConsulting · filed 17 Jan 2023 · source
Overall, the proposal and the extension of the deadline are very good. With the extension of the transitional period, the next health crisis will be averted for the first time. Proven and safe medical devices, essential for sometimes vital treatments, remain available. However, the extension of the deadline merely shifts the problems to the future.
Filed in German · English published by the European Commission
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.
MeTeCo - MedizinTechnikConsulting · filed 23 Jan 2026 · source
As a consultant with many years of experience in the medical device industry, particularly for small and medium-sized manufacturers and start-ups, I consider the creation of detailed regulations for Notified Bodies to be essential and long overdue, especially those that lead to a better reliability for the time required for conformity assessment and the costs that have to be expected.
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