A Clinical Evaluation Report (CER) is a comprehensive document that contains information and results generated from the evaluation of the clinical safety and performance of a medical device. It is a critical component of the medical device regulatory submission process, demonstrating the sufficiency of clinical evidence to verify the device’s safety, performance, and clinical benefits when used as intended.
The Clinical Evaluation Report plays a crucial role in demonstrating the safety and effectiveness of a medical device to regulatory authorities, healthcare professionals, and patients. It serves as the basis for obtaining regulatory approvals and maintaining the device’s compliance with ongoing post-market surveillance requirements.
Overall, the CER is a key document in the medical device development and approval process, providing a comprehensive overview of the clinical evidence and ensuring that patients receive safe and effective medical devices that meet the required regulatory standards.
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