Clinical Evaluation

The clinical evaluation has a special importance in the life cycle of every medical device. Based on clinical data collected in the course of systematic literature reviews and clinical trials -, the efficacy and safety of medical devices can be assessed transparently and validly. In addition to potential contraindications (e.g. should certain groups of individuals not be treated?) and delivery mechanisms (e.g. can the effect of the medical device be improved by parallel application of specific substances?), information on potential risks (e.g. side effects) is one of the core contents of the clinical evaluation.  By comparing clinically confirmed advantages and disadvantages of a medical device, the benefits of the medical device can be clearly demonstrated.

In general, the clinical evaluation of medical devices is based on the fourth revision of the MEDDEV Guidance Document 2.7 / 1 of the European Commission. Beside the essential requirements (e.g. the systematic literature search), the general considerations, the aims and the methodology of clinical evaluations, this guideline describes also their necessity.  In addition, instructions for evaluating clinical data and descriptions of the qualification or training of evaluators (e.g. higher education with at least 5 years of relevant experience) are an important part of this document.

In order to accomplish the extremely complex steps involved in the clinical evaluation and to ensure a smooth process of the approval process, CCMD would like to support you in the clinical evaluation of your medical device.  Our service portfolio includes:

1. the preparation of a clinical development plan for your medical device,
2. the scope definition (Scope),
3. the identification of data sources (systematic literature search, clinical trials, etc.),
4. the objective assessment of these clinical data as well as
5. the analysis of clinical data regarding the safety and effectiveness of your medical device.

Through our experience in conducting clinical assessments, we want to help you meet the requirements set by the European Commission in a targeted and complete manner.