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What is a CER clinical evaluation report?

A Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation of your medical device. A CER consists of analyzed clinical data that was collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices.

Why is CER Needed?

The CER documents a device's entire clinical evaluation process and is required to achieve regulatory compliance for marketing in the EU. Essentially, the CER outlines the assessment and the clinical data that determine if evidence sufficiently verifies the clinical safety and performance of the medical device.

What is the purpose of clinical evaluation plan?

The purpose of a CEP is to define the scope and document the approach of a clinical evaluation. The CEP should provide an identification of the general safety and performance requirements that require support from clinical data, which shall later be addressed in the clinical evaluation.

How do you write a clinical evaluation?

Writing a Clinical Evaluation Report: 5 Quick Tips Define a CER protocol and strategy. Demonstrate equivalence. Evaluate literature review data. Determine requirement for clinical investigation. Monitor post-market activities.

What is included in a clinical evaluation report?

A Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation of your medical device. A CER consists of analyzed clinical data that was collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices.

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What is included in a clinical evaluation?

What is clinical evaluation? Clinical evaluation is a set of ongoing activities that use scientifically sound methods for the assessment and analysis of clinical data to verify the safety, clinical performance and/or effectiveness of the medical device when used as intended by the manufacturer.

How do you perform a clinical evaluation?

There are four discrete stages to perform a clinical evaluation of a medical device. Stage 0: Scope and plan. ... Stage 1: Identification of pertinent data. ... Stage 2: Appraisal of pertinent data. ... Stage 3: Analysis of the clinical data. ... Stage 4: Finalize the report.

What does a clinical evaluation do?

[it] means as a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance of the device including clinical benefits of the device when used as intended by the manufacturer.

How do you write a clinical evaluation report?

Writing a Clinical Evaluation Report: 5 Quick Tips Define a CER protocol and strategy. Demonstrate equivalence. Evaluate literature review data. Determine requirement for clinical investigation. Monitor post-market activities.

How do I write a clinical evaluation report?

How to prepare a Clinical Evaluation Report for medical devices General information: device and manufacturer name. Concise physical and technical device description and intended application. Outline of intended therapeutic or diagnostic claims. Clinical evaluation and data types. Summary of clinical data and review.

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