EU Procedures & Regulations
All sensitive applications of silicones are thoroughly regulated by sector-specific legislation to ensure their safety. This includes cosmetics, food contact materials, and medical applications.
Silicone in Medical Applications
Silicone materials can be manufactured and used for a wide range of different applications and must meet high quality standards. The manufacturing of materials for medical applications is particularly strictly regulated, in Europe as well as in other regions of the world.
The EU updated its Medical Device Regulation in 2017, replacing all existing directives.