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
- This course is designed for engineers or senior technicians working in the field of micro and nanotechnologies in public or industrial laboratories, who need to solve problems related to controlling the properties of materials at the nanometric scale during their development and/or integration into devices.
- Organizers: INSTN Grenoble (CEA)
- June 17 to July 3, 2025
- Website: https: //instn.cea.fr/formation/nano-caracterisation-pour-letude-des-materiaux-et-structures
- Joint Regulatory Risk Assessors Summit
- Organizers: the Horizon Europe projects ACCORDs, iCare, MACRAMÉ, and nanoPASS
- Object: Addressing the needs of industry and regulators in assessing the safety and sustainability of advanced materials
- Location: OECD
- Website: https://icareproject.eu/…advanced-materials
- 18th meeting of the “nano and health” dialogue committee
- Organizer: ANSES
This sheet was originally created in February 2019
Notes and references
- 1Nanomaterials in Medicines and Medical Device, ANSM, undated, it was written after 2017