The PMS process is focused on the collection and analysis of the data that comes from various sources and is carried out according to a PMS plan to be established for each MD in order to:

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PMS Process and Risk
Management Plan: what is it?

2. The PMS process is focused on the collection and analysis
of the data that comes from the various sources and is
carried out according to a PMS plan to be established for
each MD in order to:
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Update the benefit-risk determination and
improve the risk management;
Update the design and manufacturing
information, the instructions for use and
the labelling;
Update the clinical evaluation;
Update the summary of safety and clinical
performance;
PMS Plan For Each MD

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Identify the needs for preventive, corrective
or field safety corrective action;
Identify options to improve the usability,
performance and safety of the device;
Contribute to the post-market surveillance of
other devices;
Detection and reporting of trends.
Risk management requirements for post-
market surveillance for medical devices.

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With PMS becoming a duty for medical device
manufacturers, the effective risk management system
becomes a priority as well as one of the three basic
elements that ensure compliance and safety, alongside with
PMS and clinical evaluation

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Risk Management Plan

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According to the MDR, manufacturers are expected to provide
evidence of a risk management plan created for the whole
lifecycle of products. Such plans should be used for tracking
and reducing any potential hazards and ensuring the safety
of the devices.

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