BIORIMA-Towards a Risk Management Framework for nano-biomaterial used in medical devices and advanced therapy medicinal products.

Nanotechnology offers the opportunity for significant advancements in several healthcare sectors through applications in imaging, diagnostics, therapeutics and regenerative medicine. Despite the largely anticipated benefits from nano-biomaterial, there are still uncertainties related to undesired adverse biological effects. The fundamental issue is that the research and development of the nano-biomaterial has progressed faster than the generation of adequate data and methodologies to assess nano-biomaterial risk. This has made it difficult to build risk management strategies that ensure nano-biomaterial are safe as well as effective.
Therefore, there is need for an approach to manage the potential risks of nano-biomaterial to ensure nano-biomaterial sustainability while supporting their innovation and market growth. Consequently, the EU funded Horizon 2020 BIORIMA (BIOmaterial RIsk Management) project aims to generate an overarching framework for risk assessment and management of nano-biomaterial used in medical devices and advanced therapy medicinal products, covering patient safety as well as the risks along the life cycle to medical staff, workers exposed to NBMs during production, end-of-life treatment as well as for the environment.