Nanomaterials are increasingly used in medical devices, as their benefits are now being realised. However, increasing use has also led to more regulatory scrutiny.
Nanomaterials are defined by Recommendation 2011/696/EU as unbound or aggregate particles where at least half of the particles have external dimensions of 1-100nm. While there are no explicit requirements in the current MDD, AIMDD or IVDD in relation to nanomaterials, these are present in the new EU Medical Devices Regulation (MDR) and IVD Regulation (IVDR), which include specific classification rules for devices incorporating or consisting of nanomaterial. This risk-based approach allows more scrutiny of nanomaterials, based on current uncertainties over their environmental, biological, and toxicological risk.
It is important that manufacturers identify the use of nanomaterials in their devices to ensure that they meet the requirements of the new Regulations. There are a number of general ISO standards on nanotechnology and toxicology of nanomaterials, and a Technical Report with guidance on the biological evaluation of medical devices containing or generating nanomaterials. However there are no specific standards on nanomaterials in medical devices.
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