The IVDR rightly aims to ensure that only safe and effective diagnostics reach the European market. Yet, its application has produced a system that is slow, bureaucratic, expensive, and does not reliably deliver the safety gains it promised. Strong regulation is vital, but the current path is not the most effective way to achieve patient safety and robust public health.
Johner Institut GmbH
Company · Germany
not in the EU Transparency RegisterThis organization files on consultations without a register number, so its record here is built from its filings alone. Register facts — staff, costs, accreditations — are not available for it.
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Their record over time
Johner Institut GmbH filed 2 positions between 6 Aug 2021 and 5 Oct 2025, across 2 of the 639 legislative files tracked here, attaching a full position paper 1 time.
What they argued
Input to the European Commission public consultation on the proposed 'Regulation laying down harmonized rules on artificial intelligence (AI Act)' by the Johner Institute 1. Preliminary remarks First of all, we would like to thank the EU Commission for the opportunity to discuss and comment on this important proposal.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
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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.
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