Society and clinical practice pose a growing demand on novel biomaterials, micro and nanotechnologies for innovative medical devices (MDs) and in vitro diagnostics (IVDR) (altogether, Medical Technologies-MTs). In addition to the challenge of time to market, the new technologies are subjected to other pressing factors such as qualification, regulation, cost, biocompatibility and the need to be applicable worldwide, according to strict standards and legislation, including the new EU Medical Device and IVD Regulation was published in May of 2017, addressing, among other issues, patient safety and the use of nanomaterials in MTs. The use of nanotechnology in medical devices, as there are interesting properties due to the nano-size (in the frame of 100 nanometers) but there are also safety and characterization challenges already not solved. Society will benefit from the adoption of “nano-enabled medical technologies”, as can be applied in nearly every medical area, with a major presence and increased importance in diagnostics, cancer, regenerative medicine, advanced therapies, neurology, cardiology, orthopedics, and dentistry. Nano-enabled medical technologies can be also applied in fighting pandemics like COVID-19
The main aim of SafeNMedtech project is to build an innovative open access platform to offer companies and reference laboratories, the capabilities, knowhow, networks and services required for the development, testing, assessment, upscaling and market exploitation of nanotechnology-based Medical and Diagnosis Devices, for the benefit of patients and the sustainability of Healthcare systems.
