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Medical Device Adverse Events and Advisory 

Notices Reporting Process 

CAPT Kimberly Lewandowski - Walker 

Senior Regulatory Officer 

Center for Devices and Radiological Health 

U.S. Food and Drug Administration
Course Prerequisites

• Successful completion of the following MDSAP training 

modules is a prerequisite to this course: 

– Introduction to the MDSAP Program 

– Overview of MDSAP Audit Process 

– MSDSAP: Management Process 

– MDSAP: Measurement, Analysis and Improvement Process
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Learning Objectives

• Explain the Medical Device Adverse Events and Advisory Notices 

Reporting process 

• Describe the purpose of auditing the Medical Device Adverse 

Events and Advisory Notices Reporting process 

• Discuss the expected outcomes from audit of the Medical 

Device Adverse Events and Advisory Notices Reporting process 

• Explain the audit tasks to include: 

– Description and related Clauses and Regulations 

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
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Learning Objectives

• Explain the Medical Device Adverse Events and Advisory 

Notices Reporting process 

• Describe the purpose of auditing the Medical Device Adverse 

Events and Advisory Notices Reporting process 

• Discuss the expected outcomes from audit of the Medical 

Device Adverse Events and Advisory Notices Reporting process 

• Explain the audit tasks to include: 

– Description and related Clauses and Regulations 

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
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MDSAP Audit Sequence
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Learning Objectives

• Explain the Medical Device Adverse Events and Advisory Notices 

Reporting process 

• Describe the purpose of auditing the Medical Device Adverse 

Events and Advisory Notices Reporting process 

• Discuss the expected outcomes from audit of the Medical 

Device Adverse Events and Advisory Notices Reporting process 

• Explain the audit tasks to include: 

– Description and related Clauses and Regulations 

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
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Purpose of Auditing

• The Medical Device Adverse Events and Advisory 

Notices Reporting process is audited to: 

– Verify that the organization’s processes ensure that 

adverse events and advisory notices are reported: 

• To regulatory authorities 

• Within required timeframes
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Learning Objectives

• Explain the Medical Device Adverse Events and Advisory Notices 

Reporting process 

• Describe the purpose of auditing the Medical Device Adverse 

Events and Advisory Notices Reporting process 

• Discuss the expected outcomes from audit of the Medical 

Device Adverse Events and Advisory Notices Reporting process 

• Explain the audit tasks to include: 

– Description and related Clauses and Regulations 

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
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Expected Outcomes

As a result of the audit of the Medical Device Adverse Events 

and Advisory Notices Reporting process, objective evidence 

will show whether the organization has: 

A. Defined processes to ensure individual device - related 

adverse events are reported to regulatory authorities as 

required 

B. Ensured that advisory notices are reported to regulatory 

authorities and authorized representatives when necessary 

C. Maintained appropriate records of individual device - related 

adverse events and advisory notices
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Learning Objectives

• Explain the Medical Device Adverse Events and Advisory Notices 

Reporting process 

• Describe the purpose of auditing the Medical Device Adverse 

Events and Advisory Notices Reporting process 

• Discuss the expected outcomes from audit of the Medical 

Device Adverse Events and Advisory Notices Reporting process 

• Explain the audit tasks to include: 

– Description and related Clauses and Regulations 

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
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Task 1

1. Verify that the organization has a process in place for identifying 

device - related events that may meet reporting criteria as defined 

by participating regulatory authorities. Verify that the complaint 

process has a mechanism for reviewing each complaint to 

determine if a report to a regulatory authority is required. Confirm 

that the organization’s processes meet the timeframes required by 

each regulatory authority where the product is marketed. 

Clause and Regulation: [ISO 13485:2016: 4.2.1, 7.2.3, 8.2.2, 

8.2.3] 

MDSAP Audit Approach
Task 1

• Additional country - specific requirements: Australia 

(TGA); Brazil (ANVISA); Canada (HC); Japan (MHLW); 

and United States (FDA) 

• Assessing conformity: 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 4: 

Medical Device Adverse Events and Advisory Notices Reporting 

Process, under task 1 
Task 1

• Links: 

– Measurement, Analysis and Improvement 

ØDuring the audit of the Measurement, Analysis 

and Improvement process: 

o Confirm that the organization has considered 

individual adverse events and trends of adverse 

events
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Task 2

2. Verify that advisory notices are reported to regulatory 

authorities when necessary and comply with the 

timeframes and recordkeeping requirements established 

by participating regulatory authorities. 

Clause and Regulation: [ISO 13485:2016: 4.2.1, 7.2.3,8.2.3, 

8.3.3] 

MDSAP Audit Approach
Task 2

• Additional country - specific requirements: Australia 

(TGA); Brazil (ANVISA); Canada (HC); Japan (MHLW); 

and United States (FDA) 

• Assessing conformity: 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 4: 

Medical Device Adverse Events and Advisory Notices Reporting 

Process, under task 2
Task 2

• Links: 

– Measurement, Analysis and Improvement 

ØDuring the audit of the Measurement, Analysis 

and Improvement process: 

o Confirm the organization has taken appropriate 

correction regarding devices already distributed 

o Confirm the organization has taken appropriate 

corrective action
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Summary

• The Medical Device Adverse Events and Advisory 

Notices Reporting process is audited as a linkage from 

the Measurement, Analysis and Improvement process. 

• When specified requirements or planned results are 

not achieved, correction and corrective action must be 

taken as necessary. 
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Conclusion

This concludes the training module for MDSAP process: 

Medical Device Adverse Events and Advisory Notices 

Reporting 
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