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:
A
c
t
i
v
i
t
MDR Requirement y
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;
A
c
t
i
v
i
t
MDR Requirement y
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.
Metric
/
Thresh
Activity Assigned To old How Often?
Incident documentation and analysis of QMO (define 1/year on
undesirable side effects ) Jan 1st
Assess feedback (customer complaints, sales Head of (define 1/year on
feedback) Product ) Jan 1st
Check SOUP for new published issues Head of N/A 2/year on
Software Jan 1st and
Developme Aug 1st
nt
Research data about similar products in the QMO (define 1/year on
market ) Jan 1st
Conduct post-market clinical follow-up activitiesHead of
as planned Medical
Team
Research scientific publications Head of
Product
Research updates of standards and legislation QMO
Analyze trends, decide on necessary measures and QMO 1 /year
Metric
/
Thresh
Activity Assigned To old How Often?
implement them
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*
• BfArM Field Corrective Actions
– Keywords:
– Filter:
– Time span:
• BfArM Recommendations
– Keywords:
– Time span:
• MHRA
– Keywords:
– Filter:
– Time span:
• Swissmedic: List of recalls and other field corrective actions
– Keywords:
– Time span:
• FDA Recalls: medical device recalls
– Keywords:
– Time span:
• FDA Maude
– Keywords:
– Time span:
• SOUP Incident Reports
– Go through SOUP list
– Research public incident reports of the last (enter time span) months
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
Trends
• Compile a list of trends as described in the section below.
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.
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