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RONNA Medical Ltd

Company · Croatia

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

RONNA Medical Ltd filed 2 positions between 2 Oct 2025 and 22 Jan 2026, across 2 of the 326 legislative files tracked here.

2025 · 1 filed2026 · 1 filed

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 2 Oct 2025source

From the SME perspective, the current legislative framework leaves too much room for individual interpretation. This becomes especially problematic when SMEs hire consultants to support the certification process. Often, consultants have experience with one Notified Body, but their approach is not accepted by another.

Implementing rules regarding requirements to be met by notified bodiesfiled 22 Jan 2026source

Uniform operation of Notified bodies towards manufacturers is more than welcome, but as the manufacturers are under burden of the regulatory requirements, the Notified body will also be, leading to two frustrated parties on the expense of the patients. Structural revision of the current legislation is necessary, with top down approach, not bottom up as this proposal implies.

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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 RONNA Medical Ltd’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 If something is wrong or out of date, email info@policyspeak.com and we will correct it.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.