In-house diagnostic devices under the EU IVDR and unwanted side-effects of intentional transparency

What is it about?

We point at the intent of the EU In Vitro Diagnostics Regulation. Provisions ensuring transparency of conformity assessment and surveillance is translated into an elaborate system of checks and balances. We argue that an abundance of parties and hand-overs results in calls for sprawling interpretations and guidelines. So also, for laboratory developed devices restricted to in-house use. The complexity of laboratory diagnostics foregoes simple standardized solutions. An abundance of quality assurance comes with opportunity costs for the health care system. The net result may be detrimental to patient care.

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