Products which are aimed to improve or change a person's appearance (cosmetic lasers, colored contacts, etc) for aesthetic purposes alone are most commonly regulated under Electromagnetic Compatibility Directive and/or the Low Voltage Directive.
With the impending Medical Device Regulation, we will find that many of these aesthetic devices which are functioning in the same manner as similar technologies with a medical intent of use (i.e. cosmetic lasers or light-therapies), will come to be classified under this legislative framework. This will require implementation and certification under the ISO 13485 and, in most cases, engaging a Notified Body to issue a CE Certificate.
- Electromagnetic Compatibility
- Low Voltage Directive
- Medical Device Regulation
- Aesthetic Product Under the NEW Medical Device Regulation