The Dutch Health and Youth Care Inspectorate authority has published a warning on its website [only available in Dutch]: IGJ | Toezichtdocumenten - Publicatie
This concerns the following medical device:
Device: Smileie aligners (clear plastic aligners)
Manufacturer: AK-Group B.V. (trading as Smileie EU) in Rotterdam, Netherlands
According to the information provided by the Dutch authority, it is not certain that these devices comply with the requirements of the Medical Device Regulation (MDR). This means that the safety and performance of these devices cannot be guaranteed.
Since these aligners were also sold in Switzerland, Swissmedic recommends that Smileie aligners should henceforth no longer be used.