October 17, 2025Clinical Chemistry

Regulatory Fragmentation in Europe and Its Risks for Patient Access and Safety: Subcontracting Work Flow Steps of In-House Diagnostic Procedures

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Authors

RNRaymond Nistor-GalloEnvironmental Software and Services (Austria)KZKurt ZatloukalMedical University of Graz KSKarin SchwenohaAustrian Society of Cardiology

Discussion

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Implication

This report identifies challenges in subcontracting diagnostic procedures under the EU IVDR, indicating regulatory impacts on patient access and safety.

Key Points

Regulatory fragmentation impacts patient access and safety in diagnostics across Europe, affecting rare diseases and precision medicine.
Laboratories increasingly face challenges due to subcontracting of in-house IVD procedures, with uncertainties in compliance under the IVDR.
Systemic challenges include the withdrawal of CE-marked IVDs and reliance on RUO products that shift regulatory burdens.
The adoption of ISO 5649:2024 could provide a pathway for safe subcontracting and compliance, but urgent coordination is needed.

Cite This Study

Nistor-Gallo et al. (2025) studied this question.

synapsesocial.com/papers/68f199d1de32064e504dd576 https://doi.org/10.1093/clinchem/hvaf123

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Implication

This report identifies challenges in subcontracting diagnostic procedures under the EU IVDR, indicating regulatory impacts on patient access and safety.

Regulatory Fragmentation in Europe and Its Risks for Patient Access and Safety: Subcontracting Work Flow Steps of In-House Diagnostic Procedures

Discussion

Member takes

Implication

Key Points

Cite This Study

Regulatory Fragmentation in Europe and Its Risks for Patient Access and Safety: Subcontracting Work Flow Steps of In-House Diagnostic Procedures

Discussion

Member takes

Implication

Key Points

Cite This Study

Also Consider

Also Consider