The fallout of the IDVR continues. An interesting quote from a recent paper: "Although the EC aimed at bringing safe and effective medical tests to the EU-market, ~9,000 tests out of ~40,000 tests got lost in transition." Nearly a quarter of tests suddenly became unacceptable? That places IVDR at just above 2.2 Sigma.
The proposed solution is to introduce, among other changes, "a more proportional, risk-based regulatory framework." Risk is all the rage right now, invoked across multiple ISO standards. It sounds great, but since "risk" is defined in the eye of the beholder, it's also a useful obfuscation.
"Risk-based" approaches in the US brought us IQCP, reducing QC to once a month. Literal lunacy.
From too strict to too permissive, who knows where this IVDR roller coaster will end... https://doi.org/10.1515/cclm-2026-0580