In brief
On 1 December 2022, Implementing Regulation EU 2022/2347 on the reclassification of groups of certain active medical devices without an intended medical purpose, as listed in Annex XVI to Regulation EU 2017/745, was published in the Official Journal of the EU.
Key takeaways
The Implementing Regulation introduces an exception to the general rule, according to which active devices that are not included in a particular risk class according to the classification rules fall into Class I, by providing that: (i) high intensity electromagnetic radiation emitting equipment that is intended for use on the human body for skin treatment is reclassified as Class IIb, unless it is intended for hair removal, in which case it is reclassified as Class IIa; (ii) equipment intended to be used to reduce, remove or destroy adipose tissue is reclassified as Class IIb; and (iii) equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields to modify neuronal activity is reclassified as Class III.
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