These products are similar to other medical devices in function and associated risk. Its safety, therefore, should be studied in the same way. Since these products have no clinical effect, it is important that their performance is demonstrated during their conformity assessment.

Manufacturers that until now manufacture these products have to adhere to the requirements of the Sanitary Products Regulation. This means that you must implement the appropriate quality system in your factories.

To market their products, manufacturers or importers can designate an Authorized Representative in the European Union.

The following products are subject to the MDR:

  • Non-prescription colored contact lenses and other products to be introduced on or into the eye
  • Horn implants and other products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy
  • Dermal fillers and other substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling
  • Equipment intended to be used to reduce, remove or destroy adipose tissue
  • Intense pulsed light machines for body hair removal and other high-intensity electromagnetic radiation (e.g., infrared, visible light and ultraviolet) emitting equipment intended for use on the human body
  • Equipment intended for brain stimulation that apply (non-surgically invasive) electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain

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