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FLC

Free Lance Consultant

Company · Italy

2
positions filed
in the 326 files tracked
2
legislative files
of 326 tracked
0
with a full position paper
attached to a submission

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.

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Their record over time

Free Lance Consultant filed 2 positions between 10 Sept 2025 and 17 Dec 2025, across 2 of the 326 legislative files tracked here.

What they argued

Simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and support of the European Medicines Agency for the expert panels on medical devices and the list of Union harmonisation legislationfiled 10 Sept 2025source

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

Implementing rules regarding requirements to be met by notified bodiesfiled 17 Dec 2025source

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.

Showing 5 of 26.

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Everything on this page comes from Free Lance Consultant’s own submissions to the European Commission — we have added nothing and interpreted nothing. If something is wrong or out of date, email info@policyspeak.com and we will correct it. If you are an individual named in a record, our privacy policy sets out your rights to correction, objection and removal.

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.