The development of nanotechnology has introduced nanomaterials (NM) into the medical device (MD) sector.
The physical-chemical characteristics of NM are very different from those of the same material from which they derive and, often, they can be modulated according to their size. Nanostructured medical devices often require complex characterization techniques.
The most frequent applications in the biomedical field are in the diagnostic and therapeutic field. Nanomaterials are also used in the nano-structuring of surfaces for dental, orthopedic and antimicrobial applications.
The Regulation (EU) 2017/745 assigns the risk class of medical devices with nanomaterials according to the internal exposure potential (i.e. the release of nanoparticles in the human body).