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GAIA AG

Company · Germany · EU Transparency Register 955540094252-19

2
positions filed
in the 326 files tracked
1
legislative file
of 326 tracked
1
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.

Who they are

Among the 925 companies & groups on this site, they rank #539 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 30 Aug 2026).

Register category
Companies & groups
Head office
Hamburg, Germany

Self-declared to the EU Transparency Register (snapshot 30 Aug 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 326 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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Everything on this page comes from GAIA AG’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.