11 - Regulatory perspectives on medical nanotechnologies

Research output: Chapter in Book/Report/Conference proceedingChapter


Manufactured nanomaterials (MNMs) are very attractive for innovative industrial sectors and for nanomedicine applications. They are already present on the market both in consumer products and biomedical applications and are expected to grow further in the near future. Conversely, concerns about the potential effects on MNMs on human health and environment as well as potential risks due to the exposure to MNMs are still open. For this reason, European regulatory bodies are actively developing specific regulatory frameworks for MNM marketing authorization. To date, the European Union covers MNMs, and, in particular, the potential risks associated with them, by the existing legislation for chemical substances, pharmaceutical products, and medical devices, even if nanomaterials are not always explicitly mentioned. This chapter presents a brief overview of some horizontal and sector-specific legislations concerning the main application sectors of MNMs outlining possible future regulatory scenarios.
Original languageEnglish
Title of host publicationMicro and Nano Technologies
EditorsFilippo Rossi, Alberto Rainer
Number of pages19
ISBN (Print)978-0-12-817838-6
Publication statusPublished - 2020


  • Manufactured nanomaterials
  • nanomedicine
  • nanodrugs
  • medical devices
  • EU legislation
  • nanomaterials regulatory framework


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