ANNEX XVI: emerging challenges for aesthetic manufacturers 

The growing use of devices that do not have a specific purpose in the medical field but that are used in both the professional and private sectors has pushed the European legislator to insert them into the EU Reg. 745/2017 (MDR) to protect not only public health, but also manufacturers and end-users. These devices are specifically identified in Annex XVI of the MDR Regulation; they predominantly comprise those used in the aesthetic field, such as coloured contact lenses, fillers or other skin injectables (except those used for tattoos) and equipment used for liposuction, lipolysis or lipoplasty. 

Faced with the need to fulfil these new obligations, manufacturers of devices for aesthetic use need to start planning an appropriate Quality Management System and preparing the Technical Documentation required by the MDR Regulation. 

The goal of including aesthetic devices within the MDR demonstrates the constant attention paid to improving safety in the interests of public health. Delays in releasing Common Specifications lead to a climate of pressure and negativity from stakeholders. Continuous alignment with the timeline and with new requirements is essential to keep manufacturers updated and ensure optimum harmonisation and adaptation. This session will describe the current understanding of requirements that aesthetic manufacturers must fulfil based on the latest available documents, and will provide a general overview of the state of the art applicable to these devices which will be impacted by the new Regulation. 


Date and time: Monday, 8 November 2021, 10.30 am (CET)

Your speakers: Dr Melania Battistella | Master aesthetic and regenerative medicine 
​​​​​​​                             Dr Christiana Hofmann | Team Lead Non-Active Medical Devices                           

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