1. Basic info

• PSUR
• Info of legal manufacturer
• Product name, variant and model
• Product composition
• Intended use
• Certification number

2. Worldwide marketing history

•  Country
•  Product name, model and variant
•  Status of registration (Valid, obsolete)
•  Initial approved date
•  Desolate date if applicable

3. Previous risk control measures

Yes or no answers in relate to terms below, evidence record if applicable

• Withdraw of approved product
• Recall
• Significant change of manufacturing process
• Revision of IFU
• Design change
• Clinical re-evaluation

4. Worldwide adverse event and recall reporting (individual and group)

• AE reporting number
• Product name, model and variant
• Venue of AE
• Time of AE
• Description of AE
• Control Measures of AE 

5. Risk analysis

Summary of safety hazards should be evaluated. If some incidents happen, the cause to this AE (performance or clinical features, design requirement, manufacturing process, storage and transport condition, operating environment) has to be analysed. The control measures are also a part of risk analysis to conclude that these hazards have no safety concerns left.

6. Conclusion

The current PRER compared to last periodic of PRER should be analysed. The acceptance of difference should be evaluated.