Introduction: The growing use of devices that do not have a specific purpose in the medical field but that are used both in the professional and private sectors, has pushed the European legislator to insert them in the EU Reg. 745/2017 (MDR) to protect not only the public health but also manufacturers and end users. These devices are specifically identified in Annex XVI of the MDR Regulation and among these are predominant those used in the aesthetic field, such as coloured contact lenses, fillers or other skin injectables (except those used for tattoos), equipment used for liposuction, lipolysis or lipoplasty.
Conclusion: Even in the absence of clear information, the manufacturers of devices for aesthetic use, having to fulfil these new obligations, shall start planning an adequate Quality Management System and prepare the Technical Documentation required by the MDR Regulation.
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