CE marking for Medical Devices: Technical Documentation for Annex XVI Devices according to Regulation (EU) 2017/745

From the publication of the new Medical Device Regulation 2017/745 manufacturers are forced to comply with the new requirements. MDR imposes obligations related to the risk management procedure, clinical evaluation, traceability of MD and many other requirements. A correct classification of the MD is necessary to identify the path to follow for the conformity assessment procedure in order to obtain the CE mark. The publication of the common specifications (CS) established that the products without an intended medical purpose listed in Annex XVI are also covered under the MDR. Thus, the scope of this thesis is to develop the Technical Documentation necessary to complete the certification procedure for aesthetic devices of Annex XVI . The Technical Documentation was developed for a family of devices used for photoepilation treatments of the company Elits Group. The Technical documentation was developed following Annex II of the MDR and includes the risk management, the biocompatibility, the usability test and the clinical evaluation report (CER). From the Technical documentation the main properties of the devices under study are described. They are active electrical devices which exploit laser radiation and selection phototermolysis for hair removal purposes. There are two variants of the device. The first uses 808nm diode laser radiation, while the other is available in three configurations: Single Band (808nm), Dual Band (808 & 1064nm) and Trial Band (755, 808 and 1084nm). The risk management was performed according to ISO 14971:2019 and many electrical, thermal, mechanical and biological risks were analysed. Moreover, risks associated to operating instructions, error of use and those specific of the technology are discussed too. Suitable control measures were adopted to minimize these risks. All the materials directly in contact with the consumer or with the operator are biocompatible according to the ISO 10993-1:2018. strong rationals have been used in order to avoid biocompatibility testing. The devices have performed usability tests to prove that the products have been implemented in a correct and functional manner. The devices capable of fulfilling all their functions. The clinical evaluation takes data primarily from equivalent MD in the literature in order to confirm the safety and performance of the devices under study. In conclusion, this Technical Documentation, developed for Annex XVI devices, was carried out with the aim to complete as soon as possible the certification procedure.