European Certification Procedures for Medical Devices: Technical Documentation for Annex XVI Medical Devices in Relation to the New Medical Device Regulation 2017/745

Regulation 2017/745 on medical devices (MD) upset the regulatory framework of the medical field. From 26 May 2021, when Medical Device Regulation (MDR) applied, manufacturers began the challenge to comply with the new requirements, despite having a certain period to adapt to them. MDR imposes obligations concerning the safety of MD, the risk classification procedure, the clinical evaluation, the traceability of MD, the post-market surveillance system, and many other requirements. The risk class of a MD defines the conformity assessment procedure for that device that may also involve a notified body. By the time the transitional period ends, manufacturers need to have passed the conformity assessment to place the CE marked devices on the market under Regulation 2017/745. However, novelties have come also for manufacturers of devices without a medical purpose included in Annex XVI of MDR. These devices will have to comply with Regulation 2017/745 as soon as the regulation named Common Specifications (CS) will apply. Thus, the current work aimed to develop the technical documentation for aesthetic Annex XVI devices in view of the next certification procedure under MDR. Specifically, the documentation was produced for one laser for hair removal and two devices intended for lipolysis of the company Elits Group. The documents were developed following the Annex II of MDR, including risk management in line with ISO 14971:2019 and the clinical evaluation report. From the results, it is possible to appreciate the main characteristics of the devices, such as the components, the principle of functioning, the technical characteristics, and several other features. They are active electrical devices driven by software and mains-operated. The laser emits light energy at 808 nm, regulated through the frequency, fluence, and pulse duration. Instead, the two devices for lipolysis act through several principles, including ultrasound, radiofrequency, mechanical pressure, light at low intensity, and electrical current. The applicators are made with materials biocompatible with human tissues according to ISO 10993-1:2018. Regarding the risk analysis, many possible electrical, thermal, and mechanical hazards and those associated with errors of use and reduced functions were taken into account and qualitatively evaluated. When the risks were not acceptable, control measures were adopted to minimize them. These measures mainly regard the design and manufacture according to harmonized standards and the adoption of prescriptions contained in the instructions for use. Instead, the clinical evaluation was carried out through data coming from equivalent MD from literature. The data collected provided sufficient evidence to prove that the devices under examination work efficiently and safely. To conclude, manufacturers of Annex XVI devices are waiting for the official release of CS by the European Commission to begin the certification procedure under Regulation 2017/745. Thus, the documentation provided in this work for the aesthetic devices was an attempt to be prepared to comply with MDR in the near future.