
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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Upcoming Nano Agenda

- MOOC from April 28 to June 22, 2025
- Public who has carried out two or more years of scientific studies at university, as well as professionals or the self-educated who want to discover, learn more or acquire specific knowledge in some area of nanoscience.
- Organizer: Paris Saclay University
- Course paln:
- Theme 1: Introduction to nanoscience and nanotechnology – Let’s lay the foundations and discover the key concepts of this field.
- Theme 2: How can you “see” and fabricate nano-objects? We will discover what tools are used to observe matter at these scales and what techniques the scientist can use to make objects that are only a few billionths of a meter in size.
- Theme 3: Nanochemistry – From carbon to porous solids and nanoparticle synthesis; applications of the field.
- Theme 4: Nanophysics – Quantum effects and nanoelectronic devices; optical nanostructures: the confinement of light and emission; nanosensors; applications of the field.
- Theme 5: Nanobiology, Nanomedicine, Micro-nanofluidics – The study and manipulation of molecules; treating diseases with nanomedicine; the on-chip manipulation of liquids for medical diagnosis; applications of the field.
- Theme 6: Nanoscience and Society: Are Nanotechnologies dangerous? Societal, health and environmental issues.
- Website: www.fun-mooc.fr/en/courses/understanding-nanosciences

- E-learning program: awareness-raising for personnel who come into contact with nanomaterials during research, formulation, production, maintenance, cleaning, upkeep, etc., as well as safety coordinators or engineers, facility managers, heads of laboratories where nanoparticles are handled.
- Organizers: INSTN Grenoble (CEA)
- On the program:
- 1 – Introduction, definition and characteristics of nanomaterials
- 2 – Toxicity of nanomaterials: the state of knowledge
- 3 – Metrology and characterization of nanomaterials
- 4 – Prevention and protection against nanomaterials in the workplace
- 5 – Quiz: assessment of learning outcomes
- The 2-hour course can be viewed for one month from the date of registration.
- Website: https://instn.cea.fr/…risques-lies-aux-nanomateriaux…

- 5th Joint Symposium on Nanotechnology
- Organizers: the Fraunhofer Nanotechnology Network, with the support of the Federal Institute for Risk Assessment (BfR)
- Date: May 13-14, 2025
- Topics:
- the application of nanotechnology in various sectors, including digitalization, 2D/3D printing, carbon-based materials and battery materials
- nano on various regulations (REACh, food contact materials, cosmetics, bioagents, PPPs)
- adaptation and development of OECD Test Guidelines for nano and advanced materials (Malta Initiative)
- review on nano-specific NAMs (new approach methodologies)
- when you’re nano and you know it: dealing with uncertainty regarding the nanomaterial definition in regulatory frameworks
- …
- Website: www.isc.fraunhofer.de/…2025/5th-symposium-nanotechnology.html
This sheet was originally created in February 2019
Notes and references
- 1Nanomaterials in Medicines and Medical Device, ANSM, undated, it was written after 2017