Medical Device Regulation


The OM Bioacetate 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 use by laypeople and is not designed 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.

The recommended base curve is 5 or higher. Do not bend the temples when the frames are cold. Be cautious not to heat the frames too rapidly, excessively, or repeatedly.