Regulatory Science Framework for Nano(bio)material-based Medical Products and Devices

REFINE proposes a Regulatory Science Framework for the risk-benefit assessment of medical products and medical devices that are based on nanomedicines and biomaterials. The heart of our framework is the development of a product-specific Decision Support System that identifies the most efficient way to deliver the data required by regulation by the best-fitting methods.

REFINE will gather a wide community of stakeholders in regulation, industry, science, technology development, patients, and end-users, into a Consortium for the Advancement of Regulatory Science in Biomaterials and Nanomedicine.


REFINE has started in December 2017 and will run until February  2022.


 12 research organisations from 10 countries have formed a consortium, including RIVM. The project is coordinated by The French Alternative Energies and Atomic Energy Commission (Commissariat à l´énergie atomique et aux énergies alternatives CEA).


This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 761104.