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Clinical Support

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Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to analyse whether there is sufficient clinical evidence to confirm compliance with relevant requirements for safety and performance when using the device according to the manufacturer’s instructions for use.

Clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device. It is first performed during the conformity assessment process leading to the marketing of a medical device and then repeated periodically as new clinical safety and performance information about the device is obtained during its use. This information is fed into the ongoing risk analysis and may result in changes to the instructions for use.

Clinical data on the device can be available for a medical device with a different hierarchy of evidence. They can be in a form of high quality clinical investigations, clinical data collection systems such as registries, Equivalence data or Evaluation of state of the art. It is crucial to understand whether the clinical evidences on the device are sufficient considering the Risk Class of the device.

With a dedicated team of experts in clinical evaluations of medical devices, Eurofins Regulatory and Consultancy Services can drive Manufacturers through the development of the Medical Device and advice on appropriate strategies to overcome Clinical Evaluation challenges.

Clinical Evaluation Plan

The Clinical Evaluation Plan (CEP), as listed in MDCG 2020-6, is intended to critically evaluate and analyze the general safety and performance requirements that require support from relevant clinical data. This planning is needed to proceed with the clinical evaluation process. We can provide a structured planning of the clinical evaluation based on the device risk class.

Literature Review, data identification and data appraisal

Our experts develops dedicated protocol for the literature search to be used to retrieve published clinical data for the Clinical Evaluation of the Medical device. The focus is given on literature clinical data on the medical devices and the review of the current knowledge/ the state of the art needed for the proper conduct of the appraisal and analysis of the clinical data. Following the identification of pertinent data, each data set is subject to a dedicated appraisal to determine its methodological quality, scientific validity, and relevance to the Clinical Evaluation. We developed a score system that provides a systematic appraisal of each single clinical data set.

Clinical Evaluation Report revision or support in filing Clinical Evaluation Report

The results and the conclusion of the clinical evaluation process shall be documented in a Clinical Evaluation Report, presenting the comprehensive, systematic, and critical evaluation of the pertinent clinical data in relation to the device, in accordance with the MDR and the latest Medical Device Coordination Group (MDCG) guidelines. Our experts can provide support in completely filing the Clinical Evaluation Report or joining the Clinical Evaluation writing along with the manufacturer.

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