The "Personalised And/or Generalised Integrated Biomaterial Risk Assessment" (PANBioRA) project is conducted under the Horizon 2020 topic title "Development of a reliable methodology for better risk management of engineered biomaterials in Advanced Therapy Medicinal Products and/or Medical Devices".PANBioRA aims at providing a comprehensive solution for the time- and cost-effective risk assessment of: i) new biomaterials under health or disease states or ii) a given biomaterial for each patient in a personalized manner.It will standardize the evaluation of biomaterials and open the venue for pre-implantation, personalized diagnostics for biomaterial based applications.PANBioRA will provide a modular platform to assess risks at different aspects and length scales. This comprises antibody response, cytotoxicity/genotoxicity at cell level, systemic and local effects at tissue and connected tissues (organ-on-a-chip) level. Moreover, physicochemical and biomechanical characterisation as well as predictive modelling at systems level will complement the system. This will be achieved by connecting testing modules in a structure supported by web-based modelling and risk radar tools together with a biomechanical testing system.PANBioRA will for the first time, predict the patient specific response to a given biomaterial before its implantation. This measure will allow for the selection of the best suitable material, minimizing side effects and improving health outcomes. It will also accelerate the process of validation of the biocompatibility of new devices by providing an automated, comprehensive process for the parallel assessment of risks at different scales aiding new biomaterial discovery and commercialisation.The project has received funding from the European Union's H2020 research and innovation programme under grant agreement No 760921.www.panbiora.eu