MDR - annex XVI

Original text

Expert opinion

List of groups of products without an intended medical purpose referred to in article 1(2)

1. Contact lenses or other items intended to be introduced into or onto the eye.

2. Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.

3. 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.

4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.

5. High intensity electromagnetic radiation (e.g. 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.

6. 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.

Annex XVI defines a list of products, which have not an intended medical purpose as it is defined in article 1(2) of the MDR 2017/745.

Products without an intended medical purpose is understood that the primary mode of action (PMoA) might be physical, but not to treat an illness. Very often, these products relate to applications which are not purely medical, but might be cosmetical or tools and instruments used for cosmetic purposes.

As an example, colored contact lenses might rather be used for cosmetic purposes than to restore a physical property of the human body. The same might be true for dermal filling components used in cosmetically adjusted lips, cheeks and alike.


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