Implementing Regulation (EU) 2022/2347 laying down rules for the application of Regulation (EU) 2017/745 as regards reclassification of groups of certain active products without an intended medical purpose (Annex XVI)

The European Commission has adopted the Implementing Regulation (EU) 2022/2347 reclassifying certain active products listed in Annex XVI of Regulation (EU) 2017/745. The purpose of this act is to ensure the classification of these devices in accordance with the risks they represent, thus subjecting them to the same requirements as devices with a comparable medical purpose.

The following devices are subject to reclassification:

• High intensity electromagnetic radiation emitting equipment that is intended for the use on the human body for skin treatment;
• Equipment intended to be used to reduce, remove, or destroy adipose tissue;
• 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.

This Regulation shall enter into force on the day of its entry into force, i.e., the twentieth day following its publication in the Official Journal of the European Union (OJEU).

DOWNLOAD THE IMPLEMENTING REGULATION (EU) 2022/2347