Medical device CE marking

Two Commission Implementing Regulations concerning devices without an intended medical purpose

2022-12

The official journal of the European Union now includes two Commission Implementing Regulations on Annex XVI of the Medical Devices Regulation 2017/745 (MDR)

Regulation 2022/2346 related to Common Specifications for Annex XVI products (products without intended medical purpose). It concerns following groups of active products:

  • contact lenses
  • products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy, with the exception of tattooing products and piercings
  • substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing
  • equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty
  • high intensity electromagnetic radiation (for example, infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment
  • 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

Regulation 2022/2347 related to reclassification of groups of certain active products without an intended medical purpose. It concerns following groups of active products:

  • high intensity electromagnetic radiation emitting equipment
  • 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

The Regulations can be downloaded from our library: 2022/2346 and 2022/2347

Source: European Commission