Public authority · Germany
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Robert Koch-Institut filed 2 positions between 2 Oct 2025 and 11 May 2026, across 2 of the 665 legislative files tracked here, attaching a full position paper 1 time.
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
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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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.
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