Medical Devices – Latest Updates

The EU Commission has revised the Nanomaterial Definition

15 June 2022

The EU commission has updated the definition of nanomaterial, which was originally published in the Recommendation 2011/696/EU in 2011. The revised definition is more precise and includes particles with an elongated shape, such as a rod, fibre or tube independent from their chemical composition. The revised definition also provides specifications for particles with a plate like shape and adds a waiver for materials with a specific surface area by volume of < 6 m²/cm³. In the particle definition, single molecules have been excluded.

The new definition has been published in the Official Journal of the European Union and is applicable for various specific EU regulations, such as for chemicals and medical devices. For more information, please contact Alexander Theis.

Subscribe to our Medical Devices News

Stay up to date on regulatory issues relating to the approval and marketing of medical devices


WordPress Cookie Plugin by Real Cookie Banner