Common specifications for the groups of products without an intended medical purpose listed in Annex XVI of MDR 2017/745
-Contact lenses listed in Section 1 of Annex XVI to Regulation (EU) 2017/745.
-Contact lenses containing tools, such as antenna or microchip, contact lenses which are active devices and other items intended to be introduced into or onto the eye are not covered by this Annex.
-Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy, listed in Section 2 of Annex XVI to Regulation (EU) 2017/745.
-Tattooing products, piercings and products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of fixation of body parts are not covered by this Annex.
-This Annex does not apply to active implantable devices.
-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, listed in Section 3 of Annex XVI to Regulation (EU) 2017/745.
-This Annex only applies to the means for introduction into the body, for example syringes and dermarollers, where they are prefilled with the substances, combinations of substances or other items listed in Section 3 of Annex XVI to Regulation (EU) 2017/745.
-This Annex does not apply to active devices.
-Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty, listed in Section 4 of Annex XVI to Regulation (EU) 2017/745.
-This Annex does not apply to active implantable devices.
-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, listed in Section 5 of Annex XVI to Regulation (EU) 2017/745.
-For the purposes of this Annex, skin resurfacing includes skin rejuvenation.
-For the purposes of this Annex, tattoo removal includes removal of permanent make-up.
-For the purposes of this Annex, other skin treatments include non-medical treatment of nevi flammei, haemangioma, teleangiectasia, pigmented skin areas, and scars that are not injury within the meaning of Article 2, point (1), second indent, of Regulation (EU) 2017/745. For example, this Annex applies to devices intended to treat acne scars, but it does not apply to devices for other acne treatment. This Annex does not apply to equipment using infrared optical radiation to warm the body or parts of the body and to sunbeds.
-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 listed in Section 6 of Annex XVI to Regulation (EU) 2017/745.
-Such equipment includes devices for transcranial alternating current stimulation, transcranial direct current stimulation, transcranial magnetic stimulation and transcranial random noise stimulation.
-This Annex does not apply to invasive devices.
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