Regulating nanos in medical devices
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…
– In French :
- Workshop on nanomedicines and nanomaterial-based medical devices, LNE, June 30, 2022
- Nanomaterials: special requirements for medical devices, LNE & DeviceMed, 22 April 2022
– In English:
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
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Upcoming Nano Agenda
- International conference on metallic nano-objects for experts working in the interdisciplinary field of metallic nanoparticles, with a particular emphasis on nanoparticle synthesis and characterization, plasmonics, optics and photonics, catalysis, biomedicine, electronics, and nanoparticle recycling
- Organizers / Partners: CNRS, Bordeaux University, Bordeaux INP, ICMCB, CRPP, CBMN, ISM
- Website: https://mno2026.sciencesconf.org
- Seminar presenting the Seirich system for chemical risk assessment, with a focus on the specificities of nanomaterials.
- Organizers: Association NanoMesureFrance
- Speakers: Florian Marc (INRS)
- Website: www.eventbrite.fr/e/billets-nanomesurefrance-webinar-1984136502691
- Toxicokinetics: the fate of chemicals in the body” training course:
- the different routes of entry for toxic products
- the importance of toxicokinetics in preventing substance toxicity,
- xenobiotic absorption, distribution, metabolism and elimination
- nanoparticle toxicity
- Organizer: Association Toxicologie Chimie (ATC)
- Date: March 26, 2026
- Speaker: Nicole Proust (Research Engineer, CNRS Honorary Research Director, Palaiseau)
- Website: www.atctoxicologie.fr/…
This sheet was originally created in February 2019
Notes and references
- 1Nanomaterials in Medicines and Medical Device, ANSM, undated, it was written after 2017