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[Music] the European requirements for clinical evaluations as stated in the directives and soon to be updated in the new medical device regulations are further outlined in detail in the guidance document med dev 2 point 7.1 a complete outline on how to write a clinical evaluation report is provided in a separate wmd o course in this course we will review the important steps regulatory and notified body professionals need to consider and understand to ensure compliance with a clinical evaluation part of the essential requirements pertinent to the medical device in question this course has further taken into account the requirements for clinical evaluations stated in ISO one four one five five as well as the n bulb checklist for auditing the notified body review system of clinical data or clinical evaluation let's first start by reviewing the concepts outlined in the Med dev two point seven point one first it is important to note a very important paragraph in the introduction of this document although the document is much more extensive now and emphasizes more in depth the process of clinical evaluation its requirements must carefully be considered and not generalized for all types of medical devices definitely there is a methodology to be applied in the approach of performing the clinical evaluation of each medical device however the depth of research of existing data and need for additional prospective data clearly is largely dependent also on the innovativeness of the device and the risks involved for patients and users it is up to the manufacturer to make the necessary risks considerations and weigh these carefully in preparation for the conduct of a clinical evaluation here is the figure from the standard outlining the different stages of a clinical evaluation of existing data we will review more in depth each of these stages throughout this course each of these stages represents an action step and as such needs to be documented in the clinical evaluation report stage zero includes the clinical evaluation plan including the scope of the clinical evaluation stage one would be documented using a search protocol and justification for the criteria elaborated of such protocol Stage two should include an appraisal plan and the results thereof justifying to what extend identified data are pertinent stage three includes the analysis and conclusions reached Stage four is a compilation of the full report including the review and either includes or refers to the post market clinical follow-up plan some writers will prefer to separate each of these sections of the clinical evaluation report personally I think the information may be easier to digest by an external reviewer such as the notified body reviewer if the different sections are included in one document having said this no method is wrong it may be advisable that notified bodies develop templates which may help the manufacturers and their search also streamline the methodology and make the review easier and faster