Medical Device Regulation
The KameManNen frame is a Class I medical device according to MDR 2017/745.
This adaptable medical device is intended to be assembled with prescription lenses by trained professionals, such as opticians.
The assembled device is intended for everyday use by laypeople. It is not intended to be used as a PPE (personal protective equipment) for eye protection against mechanical impact hazards, during which the glasses could break, potentially causing injury to the face and eyes.
The trained professional assembles and verifies the device prior to use as part of their professional role.
This adaptable medical device is intended to be assembled with prescription lenses by trained professionals, such as opticians.
The assembled device is intended for everyday use by laypeople. It is not intended to be used as a PPE (personal protective equipment) for eye protection against mechanical impact hazards, during which the glasses could break, potentially causing injury to the face and eyes.
The trained professional assembles and verifies the device prior to use as part of their professional role.