Based on examples from daily work the current regulatory situation in analytical laboratory medicine services will be discussed. Guidance for assay use provided by industry tend to be non-transparent and astonishingly forbidding. In the usually accredited environments of laboratory medicine an academic culture has been developed in the past decades to override such flaws and limitation of the methods offered. Under the regulations of the EU (formerly IVDD, now IVDR) such undertakings have been forced back into the niche of “local needs, even though the shortcomings of (IVD-CE certified, FDA cleared) industrial solutions are of global nature not taking appropriate care of the needs of the stakeholders presenting the local (European) marketplace.
