Periodic Safety Update Report: Product

Periodic Safety Update Report
This report describes product-specific post-market surveillance activity output

as outlined in the Post-Market Surveillance Plan.
Product
Product Name:
Unique Device Identification (UDI):
Version:
Surveillance Period:
1. Summary
Note: Highlight which issues around safety and performance of your
device you identified.
2. Impact on Clinical Evaluation: Benefit and Performance

Are the claims made for expected benefits and performance being
met?
( ) Yes ( ) No
If not, reasons for deviation:
3. Impact on Risk Management: Risks and Benefits De-

termination
The medical device is safe and the risks correspond to the assumptions
in the risk management file:
( ) Yes ( ) No
If not, describe new risks that have been identified:
Do the clinical benefits of the device outweight the risks?
( ) Yes ( ) No
If not, reasons for deviation:
4. Results of Post-Market Surveillance Activities

Summary of Incidents and Problems
Describe incidents that happened with your device and actions taken
(e.g. adverse event reports to authorities, field safety notices to
customers, field safety actions).
1
Observed undesirable side effects
Describe incidents that happened with your device and actions taken.
Title Date Hazard in Risk Table Expected Frequency / Severity Assessment
List of CAPAs
The following CAPAs resulted from post-market surveillance activities during
product lifetime and the following CAPAs were initiated during this surveillance
period:
Summary of Customer Complaints and Problems

Overall Feedback Assessment:
(enter content)
Note: Summarize the number of customer complaints, predominant
subjects of feedback and whether there was anything of importance
regarding safety. More specifically, take into account:
• Is the overall complaint rate deemed acceptable and if so, why?
• Based on feedback, have any trends been analyzed and have
any corrective measures been taken? What is the status of such
actions?
• Has PMS data been compared to occurrence probabilities from
risk management?
Copy this table for every relevant feedback issue that you have analyzed
Subject
Feedback Source
Date
Root Cause
Assessment
SOUP Issues
Describe anything of relevance you found when going through issue
trackers of your SOUP. Also describe whether this lead to any changes,
e.g. you could have updated the SOUP to a newer version (and then
updated that entry in the SOUP list), or you identified new risks
which should be added to the risk table.
The SOUP List has been updated.
2
(Describe significant changes, e.g. new risks, if applicable)
Post-Market Data of Similar Products

Note: copy the sections below for every database that you looked
into.
BfArM Database(s)
Short description of database:
Search keywords: (Insert keywords)
Subject Description and Date Assessment Applicable (Yes / No)
FDA Database(s)
Short description of database:
Search keywords: (Insert keywords)
Subject Description and Date Assessment Applicable (Yes / No)
Summary of Post-Market Clinical Follow-Up Findings

Main Findings of Post-Market Clinical Follow-Up Activities:
Describe the main findings that were derived from your post-market
clinical follow-up.
Status of Post-Market Clinical Follow-Up Activities:
Describe or list here which PMCF activities are planned, were ad-
justed or completed. Include evidence that the post-market surveil-
lance activities are meeting their objectives. Reference the location
of the original data and the analysis performed.
State of Research and Development

Market Information on Similar Devices
Note: Describe any relevant information on similar devices in the
market, e.g. clinical studies that started with outcomes that may be
applicable to our device.
Copy this table for every issue that you evaluated.
3
Query
Results (incl. date)
Applicable?
Assessment
Scientific Literature
Note: This chapter should analyze other publications applicable to
our product if not considered already as part of the post-market
clinical follow-up.
Copy this section for every issue that you evaluated.
Short description of database: Search keywords: (Insert keywords)
ID / Title Description (incl. date) Assessment Applicable (Yes / No)
General Updates of Standards and Legislation

List legislation and standards which were updated in the meantime.
E.g. there could be a new version of ISO 13485 which could be
relevant for your company.
5. Trend Analysis
Describe trends that you identified according to the metrics and
threshold values that were specified in your post-market surveillance
plan.
For example: during the surveillance period, we received several
customer complaints related to product feature XYZ. Malfunctioning
of this software component led to XYZ cases of minor injury which
was not anticipated. Therefore, we initiated action to do XYZ (ideally,
refer here to the listed CAPAs in section 1 above).
Copy this table for every issue that you evaluated.
Hazard
Date / Time Span
Occurrence acc. to
Observation
Probability acc. to risk table
Assesment and Actions Taken
4
Updated Post-Market Surveillance Plan
List updates to Post-Market Surveillance Plan, if applicable
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What information is included in a periodic safety update report?

What types of post-market surveillance activities are described?

Periodic Safety Update Report

This report describes product-specific post-market surveillance activity output

2. Impact on Clinical Evaluation: Benefit and Performance

3. Impact on Risk Management: Risks and Benefits De-

4. Results of Post-Market Surveillance Activities

Title Date Hazard in Risk Table Expected Frequency / Severity Assessment

Summary of Customer Complaints and Problems

Post-Market Data of Similar Products

Subject Description and Date Assessment Applicable (Yes / No)

Subject Description and Date Assessment Applicable (Yes / No)

Summary of Post-Market Clinical Follow-Up Findings

State of Research and Development

ID / Title Description (incl. date) Assessment Applicable (Yes / No)

General Updates of Standards and Legislation

Template Copyright openregulatory.com. See template license.

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