The EU Commission has in place a draft implementing regulation, reclassifying certain active products without an medical intended purpose.
Certain devices that fall into the category of High intensity electromagnetic radiation emitting equipment without an intended medical purpose are due to be reclassified to ensure an appropriate conformity assessment of those active products is consistent with their inherent risks before placing on the market.
It is expected that the following will apply by a derogation from Section 6.5 of Annex VIII of the MDR:
- 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 hair removal only is reclassified as class IIa;
- 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;
- 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;
- 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.
This implementing regulation will come into force on the 20th day following its publication on the Official Journal of the EU.
Our clients should be mindful that this regulation is in draft and therefore may be amended. Once this regulation is published, we shall notify clients via our newsletter.
For a full copy of the draft regulation, click here.
