Clinical evaluation of Medical Devices

Every Medical Device must go through clinical evaluation. It is defined as the analysis and evaluation of a medical device, in order to verify the clinical safety and performance. Performing a clinical evaluation can be seen as an ongoing process conducted throughout the life cycle of a medical device. It is initially conducted during the conformity assessment process, leading to the market of a medical device. That process should be repeated periodically throughout the life cycle of the device as new clinical safety and performance information such as post-marketing surveillance reports or adverse event reports are obtained during its use.

Basic principles

The clinical evaluation should be thorough and objective. Corresponding data should be collected by multiple means including clinical trial(s). An analysis should be included in all clinical performance and data safety collected during clinical evaluation.

Clinical evaluation should verify the clinical claims made about the device, including the application of the device (e.g., target treatment group, the site of application to/in the body, method of contact with human body, indications, severity, and state of the disease, application requirements, and operation environment, etc.), method of application, contraindications, precautions, and warnings, etc.

Elements that are needed to confirm clinical claims made about the medical device are, for example:

· target treatment group

· the site of application to/in the body

· method of contact with the human body

· indications

· severity and state of the disease

· application requirements and operation environment

Conducting a clinical study

Detailed guidance on how to conduct a clinical evaluation for medical devices is given by The European Medical Device Guidelines: A Guide for Manufacturers and Notified Bodies (MEDDEV 2.7.1 Rev3).

Before a medical device manufacturer starts conducting a clinical evaluation, he supposed to define a range of the study based on the Essential requirements that need to be addressed from a clinical viewpoint.

Clinical evaluation can be conducted in three discrete stages:

· Stage 1: Identification of clinical data

· Stage 2: Appraisal of clinical data

· Stage 3: Analysis of clinical data

After completing a clinical evaluation, a report should be compiled to outline the scope and context of the evaluation of the device. It is officially known as the clinical evaluation report.