Reclassification of certain active devices without an intended medical purpose

Public health

The Medical Device Regulation includes some group of products without an intended medical purpose (listed in Annex XVI). This act ensures that certain active devices without an intended medical purpose, such as laser or intense pulsed light devices for hair removal or skin treatment; liposuction equipment or brain stimulation devices, are classified in coherence with their inherent risks. These devices will be subject to the same pre- and post-market requirements as analogous medical devices.

ID: 12972