MDSAP: Medical Device Adverse Events and Advisory Notices Reporting Process

Slide 1

I am CAPT Kimberly Lewandowski-Walker, Senior Regulatory Officer at the Center for Devices and 

Radiological Health at the U.S. Food and Drug Administration. In this training module, we will be 

reviewing the Medical Device Adverse Events and Advisory Notices Reporting process for the Medical 

Device Single Audit Program.

Slide 2

Successful completion of the MDSAP training modules “Introduction to the MDSAP Program,” “Overview 

of the MDSAP Audit Process,” “MDSAP: Management Process,” and “MDSAP: Measurement, Analysis 

and Improvement” are prerequisites to this course.

Slide 3

In this training module, we will explain the Medical Device Adverse Events and Advisory Notices 

Reporting process, describe the purpose of auditing this process, discuss the expected outcomes from 

audit of the process, and explain the audit tasks in terms of the description and related Clauses and 

Regulations for each audit task, the list of country-specific requirements and assessment of conformity 

for each audit task, and finally indicate the links of the Medical Device Adverse Events and Advisory 

Notices Reporting process to other MDSAP processes.

Slide 4

We will first begin with explaining the Medical Device Adverse Events and Advisory Notices Reporting 

process.

Slide 5

As you can see from this diagram, the Medical Device Adverse Events and Advisory Notices Reporting 

process is audited as a linkage from the Measurement, Analysis and Improvement process. The primary 

reason for this is that complaints, reportable adverse events, and nonconformities leading to recall are 

quality data sources for the Measurement, Analysis and Improvement process.

Slide 6

We will now move to a discussion of the purpose of auditing the Medical Device Adverse Events and 

Advisory Notices Reporting process.

Slide 7

The purpose of auditing the Medical Device Adverse Events and Advisory Notices Reporting process is to 

verify that the organization's processes ensure that individual device-related adverse events and 

advisory notices involving medical devices are reported to regulatory authorities within required 

timeframes.

Slide 8

Let’s discuss the expected outcomes from auditing the Medical Device Adverse Events and Advisory 

Notices Reporting process.

Slide 9

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 defined processes to ensure individual 
device-related adverse events are reported to regulatory authorities as required, ensured that 

advisory notices are reported to regulatory authorities and authorized representatives when necessary, 

and maintained appropriate records of individual device-related adverse events and advisory notices.

Slide 10

Accomplishment of the outcomes for the Medical Device Adverse Events and Advisory Notices Reporting 

process is accomplished through the completion of the audit tasks. For this process, the primary means 

of accomplishing the audit tasks is by verifying the organization meets the regulatory requirements of 

the various jurisdictions participating in the Medical Device Single Audit Program.

We will now discuss the audit tasks in terms of the description and related Clauses and Regulations for 

each audit task, the Country-specific requirements and assessment of conformity, and the Links of the 

Medical Device Adverse Events and Advisory Notices Reporting process to other MDSAP processes.

Slide 11

Task 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. 

The related clauses of ISO 13485:2016 are listed on this slide. There are no related regulations for the 

participating countries.

Slide 12

There are additional country-specific requirements for Australia, Brazil, Canada, Japan, and the United 

States. Detailed information on the country-specific requirements and how to assess conformity for this 

audit task are in the MDSAP Audit Approach, Chapter 4: Medical Device Adverse Events and Advisory 

Notices Reporting Process, under Task 1.

Slide 13

This task has a link to Measurement, Analysis and Improvement processes. Reports of individual adverse 

events are a form of feedback and must be analyzed, as appropriate, for trends requiring improvement 

or corrective action.

During the audit of the Measurement, Analysis and Improvement process, confirm that the organization 

has considered individual adverse events and trends of adverse events in the analysis of data.

Slide 14

Task 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.

The related clauses of ISO 13485:2016 are listed on this slide. There are no related regulations for the 

participating countries.

Slide 15
There are additional country-specific requirements for Australia, Brazil, Canada, Japan, and the United 

States. Detailed information on country-specific requirements and how to assess conformity for this 

audit task are in the MDSAP Audit Approach, Chapter 4: Medical Device Adverse Events and Advisory 

Notices Reporting Process, under Task 2.

Slide 16

This task has a link to Measurement, Analysis and Improvement process. It is important to remember 

that corrections and removals are indicative that the product or process does not meet specified 

requirements or planned results and the nonconformity was not detected prior to distribution.

When specified requirements or planned results are not achieved, correction and corrective action must 

be taken as necessary. During the audit of the Measurement, Analysis and Improvement process, 

confirm the organization has taken appropriate correction regarding devices already distributed, and 

taken appropriate corrective action to prevent recurrence of the conditions that caused the 

nonconformity.

Slide 17

In 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.

Slide 18

This concludes the training module for MDSAP process, Medical Device Adverse Events and Advisory 

Notice Reporting.