The document discusses key risk management concepts and obligations for medical device manufacturers according to the Medical Device Regulation (MDR), including defining risk as the probability and severity of harm, defining benefit-risk determination, and general risk management obligations for manufacturers to establish, document, implement and maintain a risk management system. The quality management system is required to address risk management, including establishing a risk management plan for each device and identifying, analyzing, estimating, evaluating, eliminating or controlling known and foreseeable risks, as well as evaluating the impact of post-market information on hazards and amending control measures if necessary.

1. The MDR references to the
following risk-related key notions
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Risk is defined as “the combination of the probability
of occurrence of harm and the severity of that harm”

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Benefit-Risk Determination is defined as “the
analysis of all assessments of benefit and risk
of possible relevance for the use of the device
for the intended purpose, when used in
accordance with the intended purpose given
by the manufacturer”

3. General obligations are defined as
“Manufacturers shall establish,
document, implement and maintain
a system for risk management”
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QMS for Risk Management:
The Quality Management Systems shall
address the following matter – “risk
management”

5. Establish and document a risk
management plan for each device;
Identify and analyze the known and
foreseeable hazards associated with
each device;
Estimate and evaluate the risks
associated with, and occurring during,
the intended use and during
reasonably foreseeable misuse;
Eliminate or control the risks;
The following requirements by the MDR
should be addressed in order to ensure
compliance and
correct benefit/risk management:
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6. Evaluate the impact of information
from the production phase and, in
particular, from the post-market;
Surveillance system, on hazards and
the frequency of occurrence thereof,
on estimates of their associated
risks, as well as on the overall risk,
benefit-risk ratio and risk
acceptability;
Amend control measures if
necessary.
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