Company · Italy
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.
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Free Lance Consultant filed 2 positions between 10 Sept 2025 and 17 Dec 2025, across 2 of the 665 legislative files tracked here.
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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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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