ACIG

ENGLISH 25 Researching the literature is therefore a complex procedure that calls for sci- entific procedure, and completing it successfully requires personal expertise regarding such a working method and, of course, regarding the product itself. Summary A clinical evaluation exhibits a systematic, scientific approach that should enable you to evaluate whether your medical product entails any known risks, whether it conforms to the current state of the technology and whether it performs its clinical purpose. These data are collected from the literature and evaluated in the clinical evaluation report. Here it is possible, and so- Figure 1: Search algorithm according to IMDRF (source: IMDRF MDCE WG N56) * some literature will address issues of safety, clinical performance and/or effectiveness Potentially relevant literature identified through the search (copy of all literature citations) Literature excluded from clinical evaluation, with reasons Literature with relevant, usable data included in the clinical evaluation, by outcome: · Device Performance*; · Device Safety*; · Device Comparability (if applicable) Literature excluded, with reasons Literature retrieved for more detailed assessment