What is a clinical evaluation?
Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device.
When is clinical evaluation undertaken?
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.
Why is clinical evaluation important?
When placing a medical device on the market the manufacturer must demonstrate through the use of appropriate conformity assessment procedures that the device complies with the relevant Essential Requirements covering safety and performance. Generally, from a clinical perspective, the manufacturer is expected to demonstrate that the device achieves its intended performance during normal conditions of use and that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of the intended performance, and that any claims made about the device’s performance and safety (e.g. product labelling and instructions for use) are supported by suitable evidence.
With regard to post market activities, manufacturers are expected to implement and maintain surveillance programs that routinely monitor the clinical performance and safety of the device as part of their Quality Management System. The scope and nature of such post market surveillance should be appropriate to the device and its intended use
We conduct the clinical evaluation in accordance with PN-EN ISO 14155, the Guidance MEDDEV: 2.7.1 Rev.3 and the Regulation of the Minister of Health from 10 March 2011 on specific conditions to be met by clinical assessment of medical devices or active implantable medical devices and covers:
- identification of the essential requirements, the fulfillment of which requires evidence based on clinical data;
- review of the available clinical data concerning the assessed product and its intended use;
- an assessment of whether the clinical data collected by the manufacturer is sufficient to prove that the device achieves its intended performance during normal conditions of use and that the known and foreseeable risks are minimized and acceptable when weighed against the benefits of the intended performance.
Work Result: The clinical evaluation report.
Benefits: Limits the risks associated with placing the product on the market
The cost and time necessary to deliver the service depends on the complexity of the product: type (eg. mechanical, electrical, etc.) class (I, IIa, IIb .III), composition.