Postmarket Surveillance Plan Template

1. Section A – Administrative Information

Model / Document PMS Plan Date:
Catalogue #: #:

Product Name: Revision: Next Plan Classification:

Review Date: ☐ Class I
Device Family Time ☐ Class IIa
Period: ☐ Class IIb or
III

2. Section B – Scope
<Include brief product description and type of users, jurisdictions/marketplace where device is
marketed, expected lifetime of device (single use or reusable), and historical safety and
performance data (if available).>

Intended use:

3. Section C – PMS Plan Objectives

<Consider the following questions when determining content for the objectives.>

 New hazards/hazardous situation; risk acceptability

 Are any misuses known?
 Does it meet users’ needs?
 Unforeseen side effects
 Can improvements be made?
 Did the state of the art change?
 Patient’s average age at implantation affecting the medical device lifetime
 User/patient training reducing the likelihood of malfunction
 Malfunction impacting benefit-risk analysis
 Are indications or contraindications ensuring safety and effectiveness
for the intended use?
 Usability issues
 Recurring malfunctions due to service/maintenance deficiencies
 Known trends representing possible source of harm
 Is the expected lifetime correct?
 Does treatment affect patient’s quality of life?

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4. Section D – Responsibilities and Authorities

<Complete Resource Allocation Matrix Table>
<List of qualifications of personnel, such as resumes, training records, certificates, job descriptions
are included in Appendix XX>

Function Individual Name Responsibilities

<Identify the resources in <Recommend having an <Identify responsibilities.>
the following table: the individual’s name entered
individuals involved in here to support
gathering, appraising, and qualifications linkage.>
analyzing results, entering
information in the
PMSR/PSUR, writing
summary statements,
reviewing the information,
and approving the overall
report.>

Example:
Servicing Representative Joe Smith, Serving Responsible for gathering warranty and
Manager service data
Training and Customer
Support
Manufacturing
Representative
Marketing Representative
Quality Assurance
Representative
Regulatory Affairs / Clinical
Affairs
Subject Matter Expert

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Identification of Postmarket Sources

5. Section E – Market and Social Media Feedback

Inputs: Responsible: Frequency:

Discussion:

<Data collection protocol – include:

 What data will be collected (positive and negative)
 Methodology – how data is collected and managed
 Document the data source, including identification of search terms, field to use, qualifiers of
data sorting, date ranges, and how data is extracted
 How data is recorded and by whom
 Location of data repository
 How data is monitored and updated
 How to ensure data integrity and quality
 Who is responsible for data integrity and quality>

6. Section F – Customer Feedback

Inputs: Responsible: Frequency:

Discussion:

<Data collection protocol – include:

 What data will be collected (positive and negative)
 Methodology – how data is collected and managed
 Document the data source, including identification of search terms, field to use, qualifiers of
data sorting, date ranges, and how data is extracted
 How data is recorded and by whom
 Location of data repository
 How data is monitored and updated
 How to ensure data integrity and quality
 Who is responsible for data integrity and quality>

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7. Section G – Trend Reporting

Inputs: Responsible: Frequency:

Discussion:

<Data collection protocol – include:

 What data will be collected (positive and negative)
 Methodology – how data is collected and managed
 Document the data source, including identification of search terms, field to use, qualifiers of
data sorting, date ranges, and how data is extracted
 How data is recorded and by whom
 Location of data repository
 How data is monitored and updated
 How to ensure data integrity and quality
 Who is responsible for data integrity and quality>

Section H – CAPA/Field Safety Corrective Actions (FSCA); Recalls;

8.
Feedback from Regulatory Authorities
Inputs: Responsible: Frequency:

Discussion:
<Data collection protocol – include:
 What data will be collected (positive and negative)
 Methodology – how data is collected and managed
 Document the data source, including identification of search terms, field to use, qualifiers of
data sorting, date ranges, and how data is extracted
 How data is recorded and by whom
 Location of data repository
 How data is monitored and updated
 How to ensure data integrity and quality
 Who is responsible for data integrity and quality>

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9. Section I – Clinical Literature/Database/Register Review

Inputs: Responsible: Frequency:

Discussion:

<Literature search on subject device and similar devices/applications>

<Data collection protocol – include:

 What data will be collected (positive and negative)
 Methodology – how data is collected and managed
 Document the data source, including identification of search terms, field to use, qualifiers of
data sorting, date ranges, and how data is extracted
 How data is recorded and by whom
 Location of data repository
 How data is monitored and updated
 How to ensure data integrity and quality
 Who is responsible for data integrity and quality>

10. Section J – Service/Installation Feedback

Inputs: Responsible: Frequency:

Discussion:

<Data collection protocol – include:

 What data will be collected (positive and negative)
 Methodology – how data is collected and managed
 Document the data source, including identification of search terms, field to use, qualifiers of
data sorting, date ranges, and how data is extracted
 How data is recorded and by whom
 Location of data repository
 How data is monitored and updated
 How to ensure data integrity and quality
 Who is responsible for data integrity and quality>

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11. Section K – Complaint Handling

Inputs: Responsible: Frequency:

Discussion:

<Data collection protocol – include:

 What data will be collected (positive and negative)
 Methodology – how data is collected and managed
 Document the data source, including identification of search terms, field to use, qualifiers of
data sorting, date ranges, and how data is extracted
 How data is recorded and by whom
 Location of data repository
 How data is monitored and updated
 How to ensure data integrity and quality
 Who is responsible for data integrity and quality>

Section L – Vigilance Reporting: Nonserious Incidents and Data

12.
on Any Undesirable Side-Effects
Inputs: Responsible: Frequency:

Discussion:

<Data collection protocol – include:

 What data will be collected (positive and negative)
 Methodology – how data is collected and managed
 Document the data source, including identification of search terms, field to use, qualifiers of
data sorting, date ranges, and how data is extracted
 How data is recorded and by whom
 Location of data repository
 How data is monitored and updated
 How to ensure data integrity and quality
 Who is responsible for data integrity and quality>

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13. Section M – Vigilance Reporting: Serious Incidents, Including Information from PSURs
Inputs: Responsible: Frequency:

Discussion:

<Data collection protocol – include:

 What data will be collected (positive and negative)
 Methodology – how data is collected and managed
 Document the data source, including identification of search terms, field to use, qualifiers of
data sorting, date ranges, and how data is extracted
 How data is recorded and by whom
 Location of data repository
 How data is monitored and updated
 How to ensure data integrity and quality
 Who is responsible for data integrity and quality>

14. Section N – Publicly Available Information from Similar Devices

Inputs: Responsible: Frequency:

Discussion:

<Data collection protocol – include:

 What data will be collected (positive and negative)
 Methodology – how data is collected and managed
 Document the data source, including identification of search terms, field to use, qualifiers of
data sorting, date ranges, and how data is extracted
 How data is recorded and by whom
 Location of data repository
 How data is monitored and updated
 How to ensure data integrity and quality
 Who is responsible for data integrity and quality>

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15. Section O – Post Market Clinical Follow-Up (PMCF)

Inputs: Responsible: Frequency:

Discussion:

<Data collection protocol – include:

 What data will be collected (positive and negative)
 Methodology – how data is collected and managed
 Document the data source, including identification of search terms, field to use, qualifiers of
data sorting, date ranges, and how data is extracted
 How data is recorded and by whom
 Location of data repository
 How data is monitored and updated
 How to ensure data integrity and quality
 Who is responsible for data integrity and quality>

PMS Data Compilation and Appraisal Methods

Number Appraisal
Report Compilation Output Type or Structure
Methods
<Numbe Example: Example: Example:
r linked <Identify how to run a report from
<Output the data into an Excel <Review each data
to the the Customer Feedback Database
spreadsheet to allow further report against the
data for each search term or filter listed.>
sorting, organization, and raw data to ensure
source in
analysis of data. there is no missing
above
Each search criteria shall be information.
table
(e.g., on a different sheet in the All data must be
1,2,3> Excel spreadsheet. included based on
Maintain the Excel the search criteria;
spreadsheet as part of raw any references to
data component and save the reportable events
data in a standardized location or FSCA reporting
for the PMS Plan/Report.> shall be clearly
identified as part of
the customer
complaint
process.>
2. Etc. Etc. Etc.
3. Etc. Etc. Etc.
4. Etc. Etc. Etc.

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5. Etc. Etc. Etc.

6. Etc. Etc. Etc.

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Data Analysis Methods for PMS Data and Established Thresholds

Data Data Analysis Presentation of Data Established Thresholds

Source Method
Number
Linked
<Enter Create a tabular listing of groups of Negative feedback shall be
number feedback information based on type; entered as a customer complaint =
here to rank feedback from highest to lowest. customer complaint.
link to >18 feedback of same type =
data preventive action.
source
Change of +/- 10 individual reports
table
= preventive action.
(e.g.,1,
2, 3)> Create a bar chart or line chart running 20% increase of any type of
the top 3 to 5 feedback types feedback year to year = preventive
organized by the year to show any action.
progression of changes from year to Increase of more than ten (10)
year for feedback. feedback (>10) by individual
feedback type = preventive action.
Create a tabular list of locations from None required.
where customer feedback is obtained
either by region or by country; rank the
feedback from different location from
highest to lowest.
Generate a bar chart with the feedback >15 (fifteen) feedback for same
organized by the product part number part number = preventive action.
2. Etc. Etc. Etc.
3. Etc. Etc. Etc.
4. Etc. Etc. Etc.
5. Etc. Etc. Etc.
6. Etc. Etc. Etc.

PMS Data Sources Trending and Threshold

No Type of Trending PMS Data Overall Time Significant Re-

. Activity Segment Period Increase Establish
Trend
Value
1. Customer feedback is not
necessary to be trended
as the product has been
on the market for a long
period of time and
historically the customer
feedback consists of

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No Type of Trending PMS Data Overall Time Significant Re-

. Activity Segment Period Increase Establish
Trend
Value
positive comments on the
use of the product.
2. Total number of Total number 24 months, >4% Annually
complaints received by the of complaints rolling on a increase of over last 24
organization; total number monthly line chart complaints month
per month; averaged over per month period
a 24-month rolling period +5
Baseline: 12.2 complaints complaints
per month on average
from
previous time
period
3. Total number of Total number 24 months, +4 increase Annually
complaints received of complaints rolling on a of complaints over last 24
grouped by each part monthly line chart by by individual month
number within the product part number part number period
family; total number per month
grouped by part number >10%
quarterly increase of
Baseline: complaints in
 3610: 8.2 complaints a quarter
per month
 3620: 4.8 complaints
per month
 3630: 1.2 complaints
per month
4. Etc. Etc. Etc. Etc. Etc.
5. Etc. Etc. Etc. Etc. Etc.
6. Etc. Etc. Etc. Etc. Etc.
7. Etc. Etc. Etc. Etc. Etc.

Summary of Actions for PMS Activities

PMS Data PMS Source Normal Activity Significant Alert Level Action Level
Source Type Trend Increase (GSPR) (GSPR)
Number
1 Customer and Recorded in the None required None None
market customer established or established or
feedback feedback required required
database

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PMS Data PMS Source Normal Activity Significant Alert Level Action Level
Source Type Trend Increase (GSPR) (GSPR)
Number
2 Customer Complaints Review risk Review risk Require change
complaints recorded, analysis report analysis report to risk analysis
evaluated, and for individual for individual including
investigated risks. risks. severity or
according to Initiate a Initiate a occurrence
procedure; preventive preventive level.
monthly report action request. action request. Review benefit-
generated risk profile.
Initiate a
corrective action
request.
3 Patient and Determination of Initiate a Review None
marketing feedback or preventive customer established or
surveys complaint action request. complaint required
entered in those database for
databases trends.
Initiate a
preventive
action request.

Postmarket Surveillance Output

<Include a summary of how the postmarket activities will be collected and summarized in the PMSR/PSUR
reports.>

Example: <The Postmarket Surveillance Report (PMSR)/Periodic Safety Update Report (PSUR) will be
generated as an output of the PMS Planning process and will be a compilation of activities associated with
postmarket surveillance. These reports are identified in the quality management system with an
identification number and linked to the Postmarket Surveillance Plan (PMS Plan) through reference to the
PMSR/PSUR document number. When changes to the PMS Plan or postmarket surveillance are required,
a review, update, and reapproval of the planning and report documentation will be initiated. The PMS Plan
is part of the product technical documentation updated and maintained through the life of the product. The
PMS Plan for the product family is referenced in the technical documentation file and the PMSR/PSUR for
location of the records. These files are maintained in accordance with the record retention policies.>

Review of the Postmarket Surveillance Plan

The postmarket surveillance, including the Postmarket Surveillance Plan, postmarket data sources, and the
associated PMSR/PSUR, shall be reviewed every <insert defined frequency>. <Insert rationale for how
frequency was determined, considering risk, whether the device is new/novel technology or Wet

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Technology; consider design changes, changes in the Indications for Use, and changes that could affect
safety and performance.>

Function Name and Title Signature Date

Author Name / Title

Reviewed by Expert Name / Title

Reviewed by Regulatory Affairs Name / Title

Reviewed by Clinical Affairs Name / Title

Reviewed by Quality Name / Title

Assurance
Reviewed by Function Name / Title

REVISION HISTORY:
Revision Date Revision History

A Initial release of the document

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