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Updated September 30, 2021

Template: Post-Market Surveillance Plan

Sven Piechottka
ISO 13485

This is a free template, provided by OpenRegulatory.

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Post-Market Surveillance Plan

This plan describes product-specific post-market surveillance activities. The general process of how to do post-market surveillance is described in SOP Post-Market Surveillance. Its outputs are saved to the Post-Market Surveillance Report.

Product

Product Name Version Surveillance Period
<your product name> <version> <e.g. 10/2020-10/2021>

1. General Considerations

Note: Whatever kind of post-market surveillance activities you define for your product, make sure to map at minimum all of these actions required by the MDR to one activity in section 2 below.

According to Annex III section 1.1 (b) MDR, the post-market surveillance plan shall cover:

MDR Requirement Activity
A proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market  
Effective and appropriate methods and processes to assess the collected data;  
Suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;  
Effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;  
Methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;  
Methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;  
Reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86;  
Systematic procedures to identify and initiate appropriate measures including corrective actions;  
Effective tools to trace and identify devices for which corrective actions might be necessary;  
A PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.  

2. Data Collection Activities

Note: In the “Metric / Threshold” column there’s a placeholder “(define)”. Replace this with the metric and threshold you’ve decided upon.

Activity Assigned To Metric / Threshold How Often?
Incident documentation and analysis of undesirable side effects QMO (define) 1/year on Jan 1st
Assess feedback (customer complaints, sales feedback) Head of Product (define) 1/year on Jan 1st
Check SOUP for new published issues Head of Software Development N/A 2/year on Jan 1st and Aug 1st
Research data about similar products in the market QMO (define) 1/year on Jan 1st
Conduct post-market clinical follow-up activities as planned Head of Medical Team    
Research scientific publications Head of Product    
Research updates of standards and legisation QMO    
Analyze trends, decide on necessary measures and implement them QMO   1 /year
Update risk management file QMO    
Compile post-market clinical follow-up report Head of Medical Team    
Compile Periodic Safety Update Report Head of Product    
Upload PSUR to Eudamed database      
Compile post-market surveillance plan and post-market clinical follow-up plan for next surveillance interval      

3. Data Collection Categories

At minimum, the information required by the process for post-market surveillance is collected. For (enter product name), the following categories of data will be collected specifically:

Information about other devices*

Other information about similar devices

Specialist literature / technical databases

Note: This chapter should analyze other publications applicable to our product which are not considered already (or typically) as part of the post-market clinical follow-up.

Serious incidents of our medical device

Non-serious incidents and undesirable side-effects of our own medical device

Feedback we collect from our partners, users, distributors, importers

4. Trend Analysis

Trend analysis is performed with a focus on undesirable side-effects and non-serious incidents. These will be monitored if they impact the benefit-risk ratio in a negative way.

Hazards in the risk table are compared to post-market surveillance results:


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