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RKI

Robert Koch-Institut

Public authority · Germany

2
positions filed
in the 326 files tracked
2
legislative files
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.

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Their record over time

Robert Koch-Institut filed 2 positions between 2 Oct 2025 and 11 May 2026, across 2 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 2 Oct 2025source

The requirements of the IVDR regarding the use of in-house methods (IH-IVD) do not fit with the tasks of national reference centres and consiliar laboratories (NRAs, KLs) and other state health laboratories. These laboratories are primarily engaged in surveillance of the most relevant pathogens and thus serve primarily public health, not the individual patient.

Filed in German · English published by the European Commission

European Health Data Space dataset descriptionsfiled 11 May 2026PDFsource

As a public health institute, we very much welcome the establishment of a minimum set of metadata elements to describe health data for secondary use. It creates binding force. However, there are formal and substantive deficiencies in the documents submitted. Errors in the naming and referencing logic are particularly noticeable.

Filed in German · English published by the European Commission

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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 6.

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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.