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 Name


Surveillance Period

<your product name>


<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


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 analyze 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 fulfill 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.


Assigned To

Metric / Threshold

How Often?

Incident documentation and analysis of undesirable side effects



1/year on Jan 1st

Assess feedback (customer complaints, sales feedback)

Head of Product


1/year on Jan 1st

Check SOUP for new published issues

Head of Software Development


2/year on Jan 1st and Aug 1st

Research data about similar products in the market



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 legislation


Analyze trends, decide on necessary measures and implement them


1 /year

Update risk management file


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*#

Make sure to not just update your clinical evaluation here and enter the same keywords as for the literature review. Also add keywords for the equivalent / similar devices you compare (such as their brand names).

Other information about similar devices#

  • Google News Search

    • Filter: (define)

    • Time span:

  • (…)

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.

  • Pubmed

    • Filter: (define)

    • Time span: last 12 months

  • (…)

Serious incidents of our medical device#

  • Incident documentation

    • Was the device involved in any event that caused, directly or indirectly, death of a patient, user or other person or to a serious deterioration in their state of health? Did the company issue a recall of the device?

    • If so, attach respective documentation (e.g. field safety notices)

    • Time span:

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

  • Feedback and customer complaints

    • Filter: hazard-related feedback, usability issues

    • Time span:

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

  • Feedback and customer complaints

    • Filter: not hazard-related feedback, feedback on performance, safety or processes

    • Time span:

The overall complaint rate is deemed acceptable if:

  • Less than 10% of complaints are associated with moderate severity of harm or higher

  • Overall number of complaints does not exceed 10% of total active users

  • (…)

Note: customize the acceptance criteria for the overall complaint rate to your setup

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:

  • If post-market surveillance leads to the finding that the estimated probability was too low (= event happened more often in post-market surveillance), actions are initiated as described in the SOP Post-Market Surveillance.

  • If post-market surveillance leads to the finding that the estimated severity was too low (= event happened led to more serious harm in post-market surveillance), a CAPA is initiated.