Regulation (EU) 2017/746 of the European Parliament and of the CouncilShow full title

1.1. Performance evaluation plan U.K.

As a general rule, the performance evaluation plan shall include at least:

• a specification of the intended purpose of the device;

• a specification of the characteristics of the device as described in Section 9 of Chapter II of Annex I and in point (c) of Section 20.4.1. of Chapter III of Annex I;

• a specification of the analyte or marker to be determined by the device;

• a specification of the intended use of the device;

• identification of certified reference materials or reference measurement procedures to allow for metrological traceability;

• a clear identification of specified target patient groups with clear indications, limitations and contra-indications;

• an identification of the general safety and performance requirements as laid down in Sections 1 to 9 of Annex I that require support from relevant scientific validity and analytical and clinical performance data;

• a specification of methods, including the appropriate statistical tools, used for the examination of the analytical and clinical performance of the device and of the limitations of the device and information provided by it;

• a description of the state of the art, including an identification of existing relevant standards, CS, guidance or best practices documents;

• an indication and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the intended purpose or purposes and for the analytical and clinical performance of the device;

• for software qualified as a device, an identification and specification of reference databases and other sources of data used as the basis for its decision making;

• an outline of the different development phases including the sequence and means of determination of the scientific validity, the analytical and clinical performance, including an indication of milestones and a description of potential acceptance criteria;

• the PMPF planning as referred to in Part B of this Annex.

Where any of the above mentioned elements are not deemed appropriate in the Performance Evaluation Plan due to the specific device characteristics a justification shall be provided in the plan.