clinical evaluation

  According to Annex VIII of the new EU Regulation 2017/745, the classification of medical devices is based on the intended use and the worst-case rule (the highest applies between the multiple applicable classes; the most critical of the multiple intended uses applies).   Substance-based DM : non-invasive consisting of a substance or mixture of substances, intended for in vitro use, fall into class III . Invasive DMs : they fall into class I if their duration of use is temporary; in- class IIA if the duration is short-term; in-class IIB if long-term. Invasive surgical DM : for short and medium-term use they fall into class IIA; if absorbed or administering medicinal products are in class IIB; if related to the heart, they fall into class III . Class III also includes breast and ear implants, surgical nets, disc prostheses, and active implants. Medical software : class IIA if the software provides...

  The requirements for the   periodic safety update report   are defined in Article 86 of the   EU MDR   2017/745. Specifically, the PSUR should include: the conclusion of the risk-benefit analysis the main results of the post-marketing  clinical follow-up Sales volume of the device and other characteristics of the population using it and, where possible, frequency of use of the device. The PSUR must be prepared for each medical device or category of medical device and must include the results and conclusions of the  post-market surveillance  analyzes data collected as a result of the  post-market surveillance plan  together with a justification and description of any preventive actions and corrective measures undertaken. Benefit-risk analysis The benefit-risk analysis is part of the  risk management process  and must be performed throughout the life cycle of the medical device. The assessment of the risks and benefits of the d...