Guide for Clinical Evaluation reporting

 

The evaluation report provides an overall evaluation of analysis of pre-market and post-market clinical data that is relevant to the device in question. The CER report must provide the medical device information for approved devices that are sold in the EU. This will report all clinical performances and safety data that has been identified and analysed.

 

Step 1: Scope and plan

To identify the medical device scope and CER report that establishes a clinical evaluation plan.

• What is the device?  consider products, models, sizes, accessories, and software versions if applicable.
• manufacturer Name and the organization’s address.
• To provide a composition of the device such as “concise” physical and chemical description of the device and materials
• Address whether the device uses pharmaceuticals, tissues, or blood products.
• Address device characteristics such as sterility and radioactivity.
• Provide a picture, diagram or drawing of the device.
• Is this a new technology, a new application of existing technology, or an innovation.
• Classify the device by group.
• How does device achieve its intended purpose.
• What is the device in the context of available options for clinical care
• What is the device’s intended purpose
• Who are the target users , including medical indications, clinical form, stage, and symptoms.
• Delve into the intended application, such as single-use, non-invasive, duration of use.
• Identify the organs, tissues or body that is effects
• Are any precautions that are included with the device.
• What is the manufacturer’s claims on clinical performance and safety
• How is the device CE marked, market-approved, and regions in which it is sold
• If any modifications have been performed, include changes to the device or major events since the last CER report

 

 

Step 2: Identification of data that is relevant and fitting.

The pre-market and post-market clinical data most be applicable to the identification purpose of the device.

• How does device achieve its intended purpose.

Stage 3:  Assessment of adjective data

The assessment will identify each set of data for the validity of scientific results, comparison to the clinical date, and the weight to the final report.

• What Sources
• Search methods
• Selection criteria for literature review
• Quality control measures
• Results

Stage 4:  clinical data assessment and evaluation

Make the conclusions about how device is compliant, while considering the essential requirements for safety and performance. The analysis of data should include:

 

• Benefit and Risk Profile (pros & cons)
• Residual Risks
• Uncertain or Unanswered questions
• The Clinical data sets that are retained by the manufacturer.
• literature review from a reliable source for the evaluation of data.
• The conclusion and appraisal of clinical data sets for inclusion, including feasibility and weighting

Stage 5: Prepare report to finalize contents.

Once data has been assessed, the evaluation of the completed analysis will be recorded. After data analysis, the evaluation report should summarize the data analysis. This report should provide evidence that the conformity assessment complies with requirements, so the device can be approved for sale in European markets. The responsibility lies with the legal manufacturer to summarize clinical data on how their device is performing for the review of notified bodies or other agencies.

• next clinical evaluation date
• current clinical evaluation date
• A signed statement from the evaluator
• Data final Release from the manufacturer
• Evaluator Qualifications
• References

Medical Devices are designed with a primary focus of enhancing patient experience. In the innovation process for the betterment of the patient, don’t let regulatory requirements create a barrier

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Send An Email:  mdd@mddltd.com

 

• Main Blog
• What is a Clinical Evaluation?
• Factors to keep in mind preparing for Clinical Evaluation.
• Clinical Evaluations and Challenges

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