Nano-Biomaterial Risk Management

The EU H2020 BIORIMA project is one of the first and largest European initiatives that 
is totally dedicated to the development of innovative and robust methodologies to 
assess and manage the risks of nano-biomaterials (NBM) that are used in medical 
devices and advanced medicinal therapy products, along their whole life cycle, and at 
the same time identify and implement suitable safety-by-design alternatives. The 
BIORIMA consortium is implementing a comprehensive method testing and validation 
program to adapt and further develop existing tools for human and environmental 
exposure and hazard assessment of NBM, beyond clinical studies. All approaches that 
are tested and developed are integrated into a risk management framework (RMF) to 
help practitioners and end-users in finding best practical solutions for testing and 
handling of NBM. The RMF will be implemented by means of a web-based and 
specially designed Decision Support System (DSS), to comply with existing relevant 
regulations, such as MDR 2017/745 or REACH. The poster describes the latest 
findings of the project after 3 years of intensive research on the hazard of NBM and of 
the underlying mechanisms that are crucial for the effects and exposure we observe in 
humans and the environment.