OpenRegulatory Template

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 or the Periodic Safety Update Report.

Regulatory References:

EU Regulation 2017/745 (MDR) Art. 84 and Annex III, Para. 1.1


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 documentation you create for your product, make sure to map at minimum all of these actions required by the MDR to one document or record in section 2 below.

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

MDR Requirement Document / Record
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.

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 legislation 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*

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

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

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

The following instructions are general placeholders. Ideally, you should add product-specific information. For example, if you know how your organization should react to the most prominent non-serious incidents that you expect, then describe more specific actions here. Also see Art. 88 MDR: “The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology used for determining any statistically significant increase in the frequency or severity of such incidents, as well as the observation period, in the post-market surveillance plan referred to in Article 84.” Disclaimer for startups: as long as your usage numbers are low (e.g. n < 2.000), it’s likely that none of your trend analysis will turn over statistically significant results.

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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