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EU health policy is on the brink of a spectacular own-goal that will harm patients and hamper innovation

Within a fewmonths from now, the supply of medical tests in Europe will be drastically reduced, limiting the range of doctors’ key resources for accurate patient diagnosis – and all because of a well-meaning but badly-implemented EU regulation. The EU regulation for in vitro diagnostic medical devices (IVDR) is due to come into force on 26 May, 2022, ostensibly to raise safety for patients. But the regulatory framework on which it relies is not yet in place, condemning thousands of in vitro diagnostic tests (IVDs) to disappear from the care system – with potentially catastrophic implications for patients. The background is described in detail in the paper by Cobbaert et al. [1] in this issue of the journal. At stake are the diagnostic tests whose results underpin more than two-thirds of clinical decisions made by caregivers in hospitals [2]. This looming predicament has triggered warnings from right across the medical world of “a cliff-edge” [3] – and the concerns are felt among clinicians, patients, academics, and researchers as much as by hospitals, laboratories and companies that produce tests [4]. When the IVDR regulation was adopted, in 2017, it was already evident that new challenges would arise from the tighter requirements governing IVD development processes and the use of in-house developed tests within testing laboratories. The new rules were designed to put in place a risk-based classification system. It imposed assessment and certification requirements on thousands of medical tests. And while it granted exemptions for class A IVDs (lowest risk class), all class B, C and D tests have to undergo notified body assessments [1]. It was confidently expected that the necessary infrastructure and regulatory apparatus would be rapidly put in place to operate the stricter regime envisaged, and a transition period was accordingly provided for. But the calculations on which it was based have proved to be woefully over-optimistic.