February 2024 SOCRA Source Journal - Journal - Page 65
CLINICAL TRIALS
Clinical trials, the best source
of evidence, are systematic
investigations undertaken on
human subjects to assess the
safety and performance of a
medical device (Table 2). They
should be used if there is no
alternative way to demonstrate
the medical device’s safety and
performance. A detailed yet
concise summary of the clinical
trials conducted on the device
should be included in the CER.
Key information for clinical
trial summaries includes a
summary of the purpose
of the clinical trial and the
clinical endpoints. The clinical
trial population enrolled,
including the number of study
participants, their gender, and
whether participants were a
homogenous cohort, must also
be included. Adverse events
or incidents must be included,
along with an explanation of
whether the adverse event or
incident was or could have
been related to the medical
device. The data collected and
statistically relevant results must
also be included in the clinical
trial summaries.
EQUIVALENCE
Evidence from predicate or
similar marketed devices may
be used to demonstrate the
safety and performance of the
subject device, especially for
products that are not high risk
(Table 3). This is known as the
demonstration of equivalence
section of the CER, which is
applicable in both the European
Union (EU) and in Australia.
When updating the CER, the
demonstration of equivalence
section must be updated. For
example, if significant changes
were made to the device, the
demonstration of equivalence
may no longer be valid. In the
EU, demonstrating equivalence
under the MDR and the In Vitro
Diagnostics Regulation (IVDR) is
significantly more difficult.
Key points for demonstrating
equivalence include that the
devices identified must have
the same intended purpose as
the subject device. Also, the
clinical, functional, technical,
and biological characteristics,
including the similarities and the
differences, must be identified
and discussed. Any differences
must be justified, and it must be
shown that these do not have
a material effect on the safety
and performance of the product
under evaluation.
Questions to consider when
demonstrating equivalence are:
• Has each of the technical
specifications been
considered?
• What characteristics are
important for this type of
device?
• How many equivalent
devices are needed?
• Who should be involved in
demonstrating equivalence?
Technical specifications are one
of the most important aspects
of the equivalence table.
Ideally, only one equivalent
device is needed; however,
there are instances where it is
necessary to identify a primary
device and other devices
for certain attributes. This
also relates to geography. In
most cases, the equivalent
devices must be approved
in the geography where the
CER will be submitted. There
are instances where a second
equivalent device is necessary.
TABLE 2:
CLINICAL TRIALS AND THE CER
•
•
•
•
•
Best source of evidence
Used if there is no other way to demonstrate safety and performance
Includes a detailed yet concise summary of clinical trials
Key information for clinical trial summaries:
Summary of the purpose of the clinical trial
◦ Clinical endpoints
◦ Clinical trial population enrolled
◦ Data collected
◦ Adverse events or incidents
◦ Statistically relevant results
SOCRA SOURCE © May 2023
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