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VeilleNanos - Regulating nanos in medical devices

Regulating nanos in medical devices

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Regulating nanos in medical devices

By the AVICENN team – Last modification April 2022

At the European level

In Europe, nanos in medical devices are regulated by Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017.

The definition of the term “nanomaterial” is close to that of the European definition “recommendation” of 2011. According to “Rule 19”, “All devices that incorporate or are made of a nanomaterial fall under:

  • Class III if they have a medium or high internal exposure potential,
  • Class IIb if they have a low potential for internal exposure, and
  • Class IIa if they have negligible internal exposure potential.

It is unclear how the exposure potentials are evaluated…

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In France

An ANSM report (published after 2017)1Nanomaterials in Medicines and Medical Device, ANSM, undated, it was written after 2017 recommends:

  • to bring evolutions to the standardization and regulation for a better identification and evaluation of nanomedicines and medical devices
  • to make changes to the R-nano register (converging with the demands of the precautionary and prevention actors)
  • increased involvement of ANSM on the subject
  • etc.

In the United States

In the United States, the Food & Drug Administration (FDA) recommendations are published in the following document: Drug Products, Including Biological Products, that Contain Nanomaterials – Guidance for Industry, April 2022

Any questions or comments? This information sheet compiled by AVICENN is intended to be completed and updated. Please feel free to contribute.

Upcoming Nano Agenda

Nanomaterials and REACh (LNE, Paris)
Nanoparticles in everyday products (ATC, Paris)
  • This module is part of the training program “Interactions between toxic chemicals and the human organism”, open to anyone with a basic scientific education (bachelor’s degree or professional experience).
  • Organizers: Association Toxicologie Chimie(ATC)
  • Speaker : Nicole PROUST, Research Engineer, CNRS Honorary Research Director, Specialist in Nanotechnologies, Arsenic, Electromagnetic Waves, Palaiseau, France
  • Website:
Characterizing and preventing risks related to manufactured nanomaterials and ultrafine particles (INRS, Vandœuvre-Lès-Nancy)
  • Training intended for occupational physicians, occupational risk prevention specialists (IPRP), company prevention specialists, prevention department staff from Carsat, Cramif and CGSS, institutional prevention specialists (Dreets, Dreal, MSA…).
  • Organizer: French National institute of research and security (INRS)
  • October 7 to 11, 2024
  • Website:…/formation/…stages…JA1030_2024

This sheet was originally created in February 2019

Notes & références

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