Question 1

What is the Meaning of Clinical Evaluation Report (CER)?

Accepted Answer

A Clinical Evaluation Report (CER) is a mandatory technical document required for the regulatory compliance of medical devices, including sophisticated diagnostic tools and certain hormone delivery systems. This comprehensive report systematically analyzes and assesses all available clinical data pertaining to a medical device to definitively verify its safety and performance when used as intended. The CER is a living document that requires continuous updating with post-market surveillance data, ensuring ongoing adherence to rigorous regulatory standards throughout the device's lifecycle.

Question 2

What is the Origin of Clinical Evaluation Report (CER)?

Accepted Answer

The concept of the Clinical Evaluation Report stems directly from European Union medical device regulations, such as the Medical Device Regulation (MDR), and has been widely adopted globally as a standard for demonstrating clinical safety. Its origin is rooted in the regulatory imperative to provide objective, evidence-based assurance of a device's clinical benefit-risk profile. The report formalizes the systematic process of clinical data appraisal and synthesis.

Question 3

What is the Mechanism of Clinical Evaluation Report (CER)?

Accepted Answer

The CER functions as a structured review mechanism by collating and critically appraising three primary categories of data: data from the manufacturer's own clinical investigations, published literature on the specific device, and published literature on equivalent predicate devices. This systematic process evaluates the sufficiency of the clinical evidence against the device's intended purpose and performance claims. The resulting report serves as the core evidence base upon which regulatory bodies, such as the FDA or European notified bodies, make critical market authorization decisions.

Clinical Evaluation Report (CER)

Meaning

Origin

Mechanism

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