Regulatory Fragmentation in Europe and Its Risks for Patient Access and Safety: Subcontracting Work Flow Steps of...

Area of Science:

• Regulatory Science
• In Vitro Diagnostics
• Medical Device Compliance

Background:

• The EU In Vitro Diagnostic Regulation (IVDR) presents challenges for laboratories utilizing in-house IVDs (IH-IVDs).
• Limited clarity exists on subcontracting discrete workflow steps under Article 5(5) of the IVDR.
• Market withdrawal of CE-marked IVDs and replacement with research use only (RUO) products shifts regulatory burden to laboratories.

Purpose of the Study:

• To identify systemic challenges amplifying regulatory uncertainty for IH-IVDs under the EU IVDR.
• To analyze the impact of fragmented implementation, quality system disparities, and RUO product adoption.
• To evaluate potential solutions for compliant subcontracting and innovation in diagnostic development.

Main Methods:

• Analysis of fragmented national IVDR implementation and ISO 15189 quality system application.
• Assessment of the impact of CE-marked IVD withdrawal and RUO product use.
• Review of Medical Device Coordination Group (MDCG) guidance, national practices, and ISO 5649:2024.

Main Results:

• Fragmented national IVDR implementation and inconsistent ISO 15189 application create regulatory uncertainty.
• Increased reliance on RUO products by laboratories accepting legal responsibility without clear regulatory protection.
• Hindered innovation in academic and translational settings due to uneven oversight and lack of harmonized compliance models.

Conclusions:

• The EU IVDR's current implementation poses significant risks to patient access and diagnostic innovation.
• ISO 5649:2024 provides a risk-based framework for safe subcontracting and compliance with the IVDR.
• Urgent cross-Member State coordination and adoption of harmonized frameworks are necessary to ensure regulatory clarity and support innovation.