Clinical Evaluation Report Sample
Given below Clinical Evaluation Report Sample along with contents. readers must consider below contents for reference only. MDR strictly insist on particular documentation in be included in the final file which is a part of product technical documentation.
Clinical Evaluation Report Contents
Below given the important medical device Clinical Evaluation Report Sample contents inline with rev 4 and MDR article 61
1. Summary (of the Report)
2. Scope of the Clinical Evaluation
- General details
- Device Description
- Device Classification
- Intended use
- Device Status
- Identification of changes
3. Clinical background, Current knowledge and State of the Art
- Clinical background
- Current knowledge and State of the art
4. Device under Evaluation
- Type of evaluation
- Demonstration of equivalence
- Data generated and held by the manufacturer
- – Post-market surveillance
- – Post-market clinical follow up
- – Relevant Pre-clinical studies
- – Biocompatibility testing (biological and clinical equivalence)
- – Bench testing (technical and clinical equivalence)
- – Electrical safety
- – Software verification and validation
- Data retrieved from literature
- Summary and appraisal of clinical data
- Analysis of the clinical data
- – Requirement on Safety
- – Requirement on acceptable benefit/risk profile
- – Requirement on Performance
- – Requirement on the acceptability of undesirable side-effects
5. Clinical Evaluation Report Conclusion
6. Date of Next Clinical Evaluation
7. Qualification of the Responsible Evaluators
8. Dates and Signatures
Clinical Evaluation Report for Medical Device
- A Clinical Evaluation Report (CER) for Medical Device is a document that contains the conclusions of the clinical evaluation performed on the medical device based on all relevant clinical data available.
- The CER and the clinical data are used together to prove the conformity of the medical device to the general safety and performance requirements.
- The CER includes the details of the clinical background, current knowledge, and state of the art which can be used to evaluate the safety and performance of the device for corresponding to its intended purpose.
- If a well-established CE marked device which is similar to the device under evaluation, then the reports of that device can be used to prove the safety and performance of the device under evaluation by claiming equivalency, provided a contract is in place between the two manufacturers.
- Details of the post-market activities conducted are also provided in the CER, which is used to answer any unanswered questions or residual risks that are not covered by the available clinical data.
- Also, the results of the various tests conducted are listed to prove the safety and performance of the device.
- During the analysis of the appraised data, the requirements on safety, performance, acceptability of benefit/ risk profile, and side-effects are assessed to establish conformity to GSPR.
- The conclusion of CER includes the acceptability of the risk-benefit profile according to current knowledge/ the state of the art in the medical fields concerned and according to available medical alternatives.
- It also includes the adequacy of the information materials supplied, whether the intended purpose and risk reduction measures are adequate and any discrepancies.
- Summary of the suitability of the device, including its IFU, for the intended users and usability aspects, any discrepancies are also included along with the adequacy of claims and its discrepancies.
- If there is consistency between the clinical data, the information materials, the risk management documentation for the device under evaluation; discrepancies should be summarized.
- The Clinical Evaluation Report sample is used to ultimately evaluate and prove the device is safe for use on humans and that it performs as expected when used according to the manufacturer’s instructions.
- Also, the CER shows that the presence of the device on the market is justified because of side-effects and risks, if any, are outweighed by the benefits of the device.