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Because of the high number of nanoparticles marketed in France in 2013 (more than 500,000) and of the high growth of the nanomedicine sector, the European Union and France have started to legislate on the issue of nanomaterials. On the one hand, France has implemented a mandatory declaration that requires various types of information. On the other hand, the European Union is finalizing the future regulatory framework on medical devices. From now on, all devices incorporating or consisting of nanomaterials will systematically be classified as class III medical devices! Therefore, manufacturers of medical devices incorporating nanomaterials should assess the potential related risks and characterize these materials during the entire life cycle of their product.
After a recap of the current context, Georges Favre will explain how LNE can help you in this mandatory process of characterization of the nanomaterials.
During this webinar, the following issues will be discussed :
- Facts and figures on the nanomedicine market
- Questions raised by the nanos
- French and European regulatory framework
- LNE’s skills