According to EU directive 2011/696/EU, the definition of Nano material is redefined in the MDR as ” A natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm – 100 nm. Fullerenes, graphene flakes and single wall carbon nanotubes with one or external dimensions below 1 nm should be considered as nano materials.
The example for the medical devices are some carbon nanotubes in orthopedic implants, polymer materials in dental cements, nano silver in the wound care products, nano silver as coatings in catheters etc. In the MDD 93/42/EEC, AIMDD 90/385/EEC and IVDD 98/79/EC does not have any explicit requirement for the nano materials rather general requirements in the elimination of risk assessed and the assessment of the material toxicity and their compatibility mentioned in the Annex I essential requirements.
In the MDR, the General Safety and Performance Requirements mentioned in the Annex I, Clause 10 has specific requirements related to the nano materials as well as the classification rule mentioned in the annex VIII chapter III rule 19 has the classification for the medical devices incorporating the nano materials
What are MDR requirements for the medical devices with the nano materials? What is the conformity assessment procedure to be followed for those products? Apart from the ISO 10993 -1 , what are other specific standards to be followed for the specific evaluation of the medical devices with the nano materials for the CE marking?