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GAIA AG

Company · Germany · EU Transparency Register 955540094252-19

2
positions filed
in the 665 files tracked
1
legislative file
of 665 tracked
1
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.

Who they are

Among the 1210 companies & groups on this site, they rank #799 by legislative files engaged, a count of participation, not a measure of influence.

0.2
declared lobbying FTE
self-declared
€10K+
declared costs / yr (floor)
0
EP accreditations
as declared to the register
2024
in the register since

Declares membership of

Self-declared to the EU Transparency Register (snapshot 14 Oct 2026).

Register category
Companies & groups
Head office
Hamburg, Germany

Self-declared to the EU Transparency Register (snapshot 14 Oct 2026); cost bands are floors, not audited totals. Reused under Commission Decision 2011/833/EU.

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Their record over time

GAIA AG filed 2 positions between 11 Sept 2025 and 19 Jan 2026, across 1 of the 665 legislative files tracked here, attaching a full position paper 1 time.

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 19 Jan 2026PDFsource

Dear Commissioner Varhelyi, As a German manufacturer of software as a medical device (SaMD), we expressly support the objective of the European Commission to reclassify devices in a way that saves time and effort and is more proportionate to their inherent risk.

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 11 Sept 2025source

The current application of MDR Rule 11 leads to a systematic over-classification of Software as a Medical Device (SaMD). Even very low-risk applications, such as self-management or adherence apps, are routinely classified at least as Class IIa under a conservative interpretation. This contradicts the MDRs founding principles, particularly Recitals 58 and 60, which emphasize proportionality and risk-based regulation.

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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.