With respect to the proposed amendments in IVDR Article 5(5)(a), allowing health institutions to transfer in house manufactured blood bank test cells for blood typing and antibody screening, when justified by patient safety or public health, constitutes an important and well founded proposal.
Haukeland University Hospital
Other · Norway
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Their record over time
Haukeland University Hospital filed 2 positions between 12 Jan 2026 and 24 Mar 2026, across 1 of the 326 legislative files tracked here.
What they argued
We welcome the Commissions initiative to revise the EU rules for medical devices and in vitro diagnostics. The current proposal for revisions to the MDR/IVDR includes important amendments regarding in-house devices (Art. 5(5)). We strongly support that these revisions should be treated as a high priority for adoption.
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