Critical issues of the regulatory pathway for nanostructured medical devices

The increasing diffusion of nanomaterials (NM) is having a remarkable impact in the domain of medical devices (MD). Hence, nanostructured MDs are becoming common, even though the associated risks must be carefully considered in order to demonstrate safety. The biological effects of NMs require the consideration of methodological issues, since already established methods for, e.g., cytotoxicity can be subject to loss of accuracy in presence of certain NMs. The need for oversight of MD containing NM is reflected by the Regulation 2017/745 on MD, which states that MD incorporating or consisting of NM are in class III, at highest risk, unless the NM is encapsulated or bound in such a manner that the potential for its internal exposure is low or negligible (Rule 19). We present a critical evaluation of the European regulatory framework of nanostructured MDs, along with the assessment of the available normative tools.