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 the 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 Determination#

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 outweigh the risks?

( ) Yes ( ) No

If not, reasons for deviation:

4. Results of Post-Market Surveillance Activities#

Market Data#

Describe sales volume of the device, e.g. amount of users and, where practicable, the usage frequency of the device.

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).

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:

  • According to the device’s post-market surveillance plan, the overall feedback and complaint rate can be deemed acceptable if (…)

  • Feedback data showed (…)

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 leads 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.

(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#

Post-Market Clinical Follow-Up activities were performed following the manufacturer’s process for clinical evaluation.

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 adjusted or completed. Include evidence that the post-market surveillance 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.

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

Assessment and Actions Taken

Updated Post-Market Surveillance Plan#

List updates to Post-Market Surveillance Plan, if applicable