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
Any questions or comments? This information sheet compiled by AVICENN is intended to be completed and updated. Please feel free to contribute.
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Other news on the topic
Upcoming Nano Agenda
- International Conference on Advanced Nanotechnology and Nano Materials
- September 22 & 23, 2025
- Website: https://advnanotech.authorsequity.org
- 15th Meeting on Nanoscience Advances (MNA 2025)
- Organized by: C’Nano (CNRS), Aix-Marseille University
- Dates: from September 29th to October 2nd
- Website: https://cnano-paca.fr/conf/mna2025/index.html
- Training for nanomaterial handlers (technicians, engineers, PhD students, researchers, etc.) and prevention assistants
- Organizers: CNRS
- Objectives: learn about the risks involved in handling nanomaterials and the prevention and protection measures to be implemented, as well as best practices for limiting exposure.
- Topics covered:
- Health effects / Risk assessment
- Preventive measures / Good laboratory practice / Time and space management / Collective and individual protection / Cleaning methods for surfaces, materials and equipment / Product storage / Product management
- Hands-on workshops:
- Implementing best practices when handling nanometric powders / Case studies / Assessment & recommendations
- Case studies: risk analysis and recommendations
- Examples of workstation design involving nanomaterials
- Website: https://formation.ifsem.cnrs.fr/training/1027/4426
This sheet was originally created in February 2019
Notes and references
- 1Nanomaterials in Medicines and Medical Device, ANSM, undated, it was written after 2017