The Federal Council of Switzerland decided to regulate the changes in the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Devices (IvDO) involving non-medical purpose products that have comparable functions and risk profiles to medical devices. This regulation will officially be enforced starting from 1 November 2023.
This provision is intended to enhance the safety of non-medical purpose products which are mainly used in cosmetics, cosmetic surgery, bodyforming, and interventional psychiatry and opticians. On the other hand, the Federal Council would like to adapt these product groups into the medical device law. Please refer to the list below for the details of the non-medical purpose product groups:
Contact lenses, or other items intended to be introduced into or onto the eye
Products designed for surgical insertion, either partially or totally, into the human body, to alter or affix body parts (except tattoo products and piercings)
Substances, the combination of substances, items intended to be used for facial, dermal, or mucous membrane filling by subcutaneous, sub-mucous, or intradermal injection, or other introduction (except tattooing)
Devices with the purpose of reducing, removing, or destroying adipose tissue (Example: devices for liposuction, lipolysis, or lipoplasty)
Devices that emit high-intensity electromagnetic radiation with the purpose of use on the human body (example: infra-red, visible light, ultraviolet), including coherent and non-coherent sources, monochromatic and broad-spectrum for skin resurfacing, tattoo, or hair removal, or other skin treatment (example: lasers, intense pulsed light equipment)
Brain stimulation purpose devices that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain
Further updates on the implementation guides and specifications will be continuously updated by Swissmedic for the non-medical purpose product groups.
Source: Swissmedic
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