First of all it should be clarified that the regulatory framework for clinical evaluation is determined by the directive 93/42/EEC (amended by the directive 2007/47/EC).
The guideline MEDDEV 2.7.1 helps manufacturers and notified bodies to proceed more efficiently with the implementation.
However the compliance with the directive is not compulsary.
It is even possible that – regarding the latest scientific developments – another approach might be more useful than handling the provisions of the guideline.
The clinical evaluation can be implemented in various ways. Central condition in Europe is the compliance with the requirements of the MEDDEV 2.7.1 document.
Approach I – Creation of the clinical evaluation built on data of literature sources – the literature route. For this type of evaluation the evident presentation of comparability of the respective product to the products described in literature is important. Original Data of a similar product demonstrate the highest degree of comparability.
Approach II – Creation of the clinical evaluation based on clinical trials/clinical studies. By this way the necessary data are generated by means of a clinical study/clinical trial. Following the study the clinical evaluation has to be prepared and constitutes a total evaluation involving all data collected from the study.
Approach III – Combination of approach I and II. Both Data from clinical studies/clinical trials and data from literature are being used in order to prepare the clinical evaluation.