Article 1
Open ↗By way of derogation from Section 6.5 of Annex VIII to Regulation (EU) 2017/745, the following groups of active products without an intended medical purpose listed in Annex XVI to that Regulation are reclassified as follows: (a) high intensity electromagnetic radiation emitting equipment as referred to in Section 5 of Annex XVI to Regulation (EU) 2017/745 that is intended for the use on the human body for skin treatment is reclassified as class IIb, unless it is intended for hair removal only in which case it is reclassified as class IIa; (b) equipment intended to be used to reduce, remove or destroy adipose tissue as referred to in Section 4 of Annex XVI to Regulation (EU) 2017/745, is reclassified as class IIb; (c) equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain as referred to in Section 6 of Annex XVI to Regulation (EU) 2017/745is reclassified as class III.