Clinical Evaluation  
  The evaluation of clinical data is not only of prime importance for the official approval process and product launch, but also for the continuing market surveillance in the field of medical devices.

MDD 93/42/EEC According to appendix X § 1 of the EU guideline 93/42/EEC as well as according to most national legislation regarding medical devices, suitability for the intended use has to be established for all medical devices and an evaluation of medical risks has to be conducted. These provisions are met by means of an evaluation of clinical data based on scientific literature, research and testing and/or on the basis of clinical studies. A clinical evaluation is required for all classes of medical devices.

Risks versus Benefits The aim of a clinical evaluation is to analyse available clinical data in order to illustrate immanent risks of the product itself or its usage and thus give a qualified critical comment on the risk-benefit ratio of the product in question. This includes benefits as well as risks of the product's intended qualities. An assessment of whether future users are sufficiently informed about remaining risks in the instructions for use and product warnings is also part of the evaluation.

Approval Process The evaluation of clinical data is part of the technical documentation and conformity assessment, and therefore has to be submitted to the notified body as part of the official approval process for medical devices, regardless of the product’s risk category. The Notified Body then composes a report on the evaluation of the submitted documents. This report can either be a separate document or a section within the overall report of the notified body as part of the approval process.