Latest news from BIORIMA after 30 months!
In these times, when COVID-19 is still challenging the world, we all have opportunities to step back and see things from a different perspective. And indeed, many of us are experiencing this pandemic not only as a challenge, but also as a time for change and renewal, be it on the political, socioeconomic or personal level, and in particular related to our existing safety and health care systems.
This pandemic emphasizes the fundamental and urgent need to develop highly innovative intelligent, and sustainable ways to be prepared for unexpected future events and to better meet the risks that may come along with them.
The increasing convergence of cutting-edge technologies, such as nanotechnology and biotechnology, is leading to completely new advancements and breakthroughs in medical applications, including imaging, diagnostics, therapeutics, and regenerative medicine. These innovations are very much based on the development of novel nanoengineered biomaterials (NBMs), that increasingly include bio-active and bio-mimetic materials. However, there are concerns that these new advanced materials may give rise to human health and/or environmental risks. For this reason, manufacturers must establish a risk management plan for each medical device, to identify and analyze any known and foreseeable hazards, estimate and evaluate associated risks, and show how to eliminate or control these risks, when applying for a marketing authorization of a medical device or product (according to European regulation, such as REACH or MDR 2017/745).
BIORIMA is an interdisciplinary European research initiative, and the only one of this kind to develop robust and validated methodologies to assess and manage any risks of NBM's when used in medical devices (MD) and advanced medicinal therapy products (AMTP), beyond clinical tests, including safe-by-design strategies to minimize or eliminate these risks.
