Clinical Evaluation Documentation
Clinical evaluation of a medical device is a crucial step in obtaining and maintaining EU market approval. It involves the continuous collection, generation, appraisal, and analysis of clinical data related to the device.
To ensure credibility, the regulatory documents supporting clinical evidence for the device’s safety and performance must comply with strict regulatory guidelines such as MDR 2017/745 and MEDDEV 2.7/1 version 4.
These documents are essential for device development and approval.
A well-designed and clearly written clinical evaluation plan and documentation are crucial for demonstrating compliance with regulatory requirements and ensuring the safety and performance of medical devices (Class I to III), including both new and legacy devices.
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