As a consultant with many years of experience in the medical device industry particularly for small and medium-sized manufacturers and startups I welcome the European Commissions proposal to simplify the regulatory framework for medical devices. Overall, the proposed changes are appropriate for easing the burden on small and medium-sized manufacturers and reducing their excessive administrative workload.
MM
MeTeCo - MedizinTechnikConsulting
Company · Germany
not in the EU Transparency RegisterThis organization files on consultations without a register number, so its record here is built from its filings alone. Register facts (staff, costs, accreditations) are not available for it.
4
positions filed
in the 665 files tracked
3
legislative files
of 665 tracked
0
with a full position paper
attached to a submission
Counts here are a floor, never a total: they cover the 665 consultation files tracked so far (57,774 submissions, mostly 2021–26), so an organization's real filing history is larger, not smaller.
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Their record over time
MeTeCo - MedizinTechnikConsulting filed 4 positions between 17 Jan 2023 and 31 Jul 2026, across 3 of the 665 legislative files tracked here.
2023 · 1 filed2025 · 1 filed2026 · 2 filed
What they argued
The Commission's initiative to simplify EU regulations for medical devices and the opportunity to make proposals in this regard are welcome. As a long-time consultant to the medical device industry, particularly small and medium-sized manufacturers and start-ups, I consider the following simplifications to be essential and long overdue: - Fast-track procedures and simplified conformity assessment for innovative…
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
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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