1. Información básica

• PSUR
• Info of legal manufacturer
• Nombre del producto, variante y modelo
• Product composition
• Intended use
• Número de certificación

2. Historia del marketing a nivel mundial

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

3. Medidas de control de riesgos previas

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

• Retirada del producto aprobado
• Recall
• Cambio significativo en el proceso de fabricación
• Revisión de las instrucciones de uso
• Cambio de diseño
• Reevaluación clínica

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

• AE reporting number
• Product name, model and variant
• Lugar de celebración de AE
• Hora de AE
• Descripción de AE
• Control Measures of AE 

5. Análisis de riesgos

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. Conclusión

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