Information on the Subject Device
The intended use in Japan, target patients, structure and principle of operation, product characteristics, development history and clinical positioning.
How to Prepare a Clinical Evaluation Report (CER) for Japan
A Clinical Evaluation Report (CER) brings together and appraises existing literature and clinical data to explain a medical device’s safety and effectiveness for its intended use in Japan.
Preparation proceeds from defining the evaluation scope to literature searching, data appraisal, integrated analysis, and conclusions. A CER does not automatically remove the need for a clinical trial; the adequacy of existing evidence and the need for additional data must be assessed for each device.
For project-specific help, see clinical evaluation report consulting for Japan.
First Define What the Clinical Evaluation Needs to Demonstrate
Before preparing a CER, confirm the intended use to be submitted in Japan, target patients, product characteristics, and differences from approved devices.
For some products, nonclinical testing and existing documentation alone may not be sufficient to explain clinical safety and effectiveness.
In other cases, existing literature, overseas clinical data, and clinical use experience may be used for the evaluation.
For acceptance considerations, see JFMDA’s Part 2 guidance, hosted by PMDA in Japanese. This is a practical reference, not legislation or a general clinical-trial exemption: assess intended use, differences from approved devices, and the quality and completeness of the evidence.
If questions remain about whether existing evidence is sufficient, organize the available data and unresolved issues before considering a PMDA consultation. A consultation is not mandatory for every product.
What to Document in the Report
Scope of Evaluation
The safety, effectiveness and performance questions and the boundaries of the evaluation.
Data Search and Collection
The search and collection methods, execution records, included sources and reasons for exclusion.
Data Appraisal
The quality and applicability of each source, how it is used and its limitations.
Analysis of Safety and Effectiveness
The analysis and supporting evidence for each safety and effectiveness question.
Conclusion
The conclusions supported by the clinical evidence, benefits and risks, and remaining uncertainties.
From Defining the Evaluation Scope to Reaching a Conclusion
See Chapters 2 (report structure) and 3 (preparation steps) of JFMDA’s Part 1 guidance, hosted by PMDA in Japanese. The following are procedural examples, not accounts of client projects.
- 01
Define the Scope of Evaluation
Turn the intended use in Japan, target patients and method of use into questions the evaluation must answer. Map each question to the evidence that will address it.
- 02
Consider the Comparator
For data from similar devices or previous models, create a comparison table using the items listed below. For each difference, state its effect on safety and effectiveness and the basis for that assessment.
- 03
Develop the Literature Search Plan
Set the search and selection methods before searching. Record the results and reasons for inclusion or exclusion so that selection can be traced back to the plan.
- 04
Appraise Literature and Clinical Data
For example, if a publication covers different patients or a different method of use, state how far its findings apply to the Japanese application. Distinguish a relevant publication from evidence sufficient to support a conclusion.
- 05
Perform an Overall Evaluation of Safety and Effectiveness
Compare the sources for each evaluation question, showing conflicting findings and limitations as well as agreement. Discuss safety and effectiveness using the full evidence base, not a single favorable publication.
- 06
Organize the Conclusion and Remaining Uncertainties
Separate issues addressed by existing evidence from those needing additional information or authority consultation. Check that the conclusions do not conflict with the intended use in the application form and STED or with the nonclinical evaluation.
Ensure Reproducibility in the Literature Search
To ensure that the search process can be reproduced later, record:
- Databases used
- Search date
- Search terms
- Search strings
- Search period
- Inclusion criteria
- Exclusion criteria
- Handling of duplicate publications
- Reasons for inclusion and exclusion
It is important to evaluate the evidence consistently according to a predefined method rather than selecting only favorable literature.
When Using Data from Similar Devices or Approved Devices
When using data from another product, do not rely only on similarities in shape or intended application. Organize the similarities and differences in:
- Intended use
- Target patients
- Materials
- Structure
- Performance
- Method of use
- Site and duration of contact
- Clinical positioning
Place the proposed device and the device described in the publication side by side in the table. For example, where the method of use differs, explain the effect on interpretation of the clinical results and identify the supporting material. Do not end the comparison with a statement that the devices are simply “similar”.
Points Often Overlooked When Preparing a CER
- Starting the literature search before defining the scope of evaluation
- Using a search method that cannot be reproduced
- Failing to clearly document reasons for including or excluding literature
- Insufficient assessment of differences from similar devices
- Reusing an EU MDR CER without reviewing it for the Japanese application
- Inconsistency between the conclusions of nonclinical testing and clinical evaluation
- Differences in the stated intended use between the application form or STED and the CER
Frequently Asked Questions
Can an EU MDR CER be used in Japan?
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Some of the materials may be usable, but they need to be reviewed against the content and scope of the Japanese application.
Can a clinical evaluation be based on literature alone?
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It depends on the product characteristics and the application content. The scope that can be explained with literature and the scope that requires additional clinical data should be assessed for each product.
Can you support us starting from the literature search?
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CER Preparation Support
Please contact us regarding whether a clinical evaluation is required, available data, literature searching, and CER preparation.
clinical evaluation report consulting for Japan