The aim of the Clinical Evaluation Division is the evaluation of the clinical data that support the development or the evolution of a MD and its harmonization with the European Legislation and European guidelines and recommendations for the evaluation of all medical devices.
The Clinical Evaluation Division undertakes the evaluation of the clinical information and data of the product provided in the Technical Documentation, which is submitted by the supplier company for evaluation to EKAPTY. In the context of evaluating the clinical part of the Technical File of each medical device, the Clinical Evaluation Division prepares the Clinical Evaluation Report (CER), which presents in detail the conclusions of the study and the evaluation of the biological, technical and particularly of the clinical characteristics.
In accordance with the requirements and guidelines of MEDDEV 2.7.1. rev 4, the Clinical Evaluation Report evaluates the Technical File of the product in the following fields:
- Description of the physical and chemical properties of the product, the proposed use and users and the target population
- Bioequivalence of the product, risk-benefit and risk assessment analysis
- Evaluation of the data collected from clinical trials designed and conducted to document the efficacy and safety of the product or clinical trials involving another or other products, which are however considered bioequivalent to the product under evaluation
- Literature review data documenting the clinical safety of the product and
- Post-market surveillance study analysis
The manufacturer with the help/feedback of the observations and suggestions that are presented in the Clinical Evaluation Report of the Clinical Evaluation Division of EKAPTY, corrects and improves the Technical File of the product, seeks further literature review data, while, where appropriate, conducts appropriately designed clinical trials or studies of surveillance and monitoring of the clinical data of the product after its release in the market. Hence, the Clinical Evaluation Division of the Body ensures the effectiveness and the clinical safety of the evaluated product and its harmonization with the defined standards of the European Legislation.
The Clinical Evaluation Division of EKAPTY evaluates and certifies the clinical data of almost all types of medical devices related to the medical and dental sector in the domestic or in the European market. The Division operates under the supervision and the coordination of a Scientific Director and is staffed by certified Clinical Evaluators, who are health professionals with expertise and experience in the evaluation of clinical data of medical devices according to the current European standards. The Scientific Director of the Clinical Evaluation Division of EKAPTY is responsible for the final Clinical Evaluation Report (CER) of the product and makes the final decision on the effectiveness and safety from the clinical use of the product.
