EU MDR now regulates beauty devices as medical devices

The beauty devices business is booming. The global value of the cosmetic industry amounted to over $530 billion in 2022, with an expected growth rate of roughly 4% over the next five years, while the beauty devices market size stood at $66 billion and a growth rate over 20% through 2030.

Beauty devices are products that are used on the face and body for cosmetic reasons, such as, for example, hair removal devices, liposuction devices, and colored contact lenses. The access to the European markets has been easy for these devices as the Cosmetics Regulation 1223/2009 does not apply to devices, since this regulation only applies to pastes, creams, and lotion types of products.

The business model for beauty devices is often based on the “white label” model, in which distributors buy the product from a manufacturer and put their own name and branding on it.

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