Counts here are a floor, never a total: they cover the 326 consultation files tracked so far (29,503 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.
The following are suggested: 1. Do not require new clinical evidence for products of established use that already have clinical evidence to support the claimed clinical benefit. The clinical benefit must of course be clearly explained. 2. Remove the constraints for gathering information from the market for PMCF of devices already CE marked used according to the intended purpose indicated by manufacturer 3.
Filed in Italian · English published by the European Commission
Considering that a bottleneck in the certification of medical devices is caused by: - The reduced number of Notified Bodies - The codes of the corresponding types of devices that specify the purpose of the designation the same deadlines and transparency of precesses required of Notified Bodies should also be imposed on Ministries and Accreditation Authorities for the evaluation of applications submitted by CABs.
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Turns up on the same files
Organizations that also filed on at least two of the same consultations. A shared interest in the same dossiers — not evidence of coordination, and we do not suggest any.
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Quotes are verbatim from submissions published by the European Commission, trimmed to their opening passage and never summarized by a model. Organizations only, never individuals. Reused under Commission Decision 2011/833/EU; the European Commission is not liable for this reuse.