Products which are aimed to improve or change a person's appearance (cosmetic lasers, colored contact lenses, 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 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 Devices
- Aesthetic Product Under the NEW Medical Device Regulation
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