reliable, and reproducible. [20][21][22] This is, not least, important for realizing interstudy comparisons of the thrombogenicity of different materials. According, e.g., to the regulation (EU) 2017/745 of the European parliament and of the council on medical devices, in vitro and in vivo tests are a mandatory parts within the preclinical product verification and validation (see Annex II: Technical documentation, 6.1 Preclinical and clinical data). [23] Beyond the results of these tests, also detailed information concerning the test design, respective protocols and data analysis are obligatory to meet the requirements of the regulation, particularly those formulated in the ISO standard 10993 Part 4. [24,25] Since the regulatory agencies provide recommendations rather than protocols or standard operation procedures, accepted standardizations regarding the preanalytical handling of the blood, test conditions, test parameters, reference materials, static or dynamic conditions, flow conditions, and finally, which type of cells and donors should be included is lacking. Also, standard operating procedures how the testing should be performed are lacking. [9] This has led to a situation that laboratories perform in vitro assays under substantially different test conditions, including the preanalytical characterization of blood samples, the application of blood from different species, varying anticoagulation and stabilization or storage times as well as test setups. Taking these variations into account, interlaboratory or interstudy comparisons are impossible. [8,[26][27][28] Here, we review described test methods and procedures for the assessment of the thrombogenicity of materials, prerequisites for a reproducible in vitro testing, applied test system and test parameters for the characterization of the interaction of blood components/cells and the implant. We further review and outline recent approaches that may support realizing reliable, reproducible, and laboratory independent tests.