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EU rules on medical devices also cover products without an intended medical purpose. For example: laser or intense pulsed light devices for hair removal or skin treatment; liposuction equipment; and brain stimulation devices (see Annex XVI to Regulation (EU) 2017/745 for full list).
This initiative will ensure that such devices are classified in accordance with their risks, and that they are subject to the same pre- and post-market requirements as comparable medical devices.
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