February 2024 SOCRA Source Journal - Journal - Page 66
TABLE 3:
EQUIVALENCE AND THE CER
Demonstration of equivalence:
• Evidence from predicate or similar marketed devices may be used to demonstrate the safety and
performance of the subject device.
Key points:
• Identify devices with the same intended purpose as the subject device.
• Identify and discuss clinical, technical, and biological characteristics.
• Establish functionality/characteristic equivalence.
Questions to ask:
• 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?
If, for example, a device that
is available in the EU is not
available in China, another
equivalent device that is
available in China is necessary.
Demonstrating equivalence
is a team effort. Engineering,
regulatory, clinical, and
marketing should all be
involved. Each department will
be able to provide different
insights.
Literature
The recent revision of the MDR
made many changes related
to literature reviews, which
are used to identify data that
are not held by the device
manufacturer (Table 4). Sources
for literature reviews include the
following:
• Scientific literature
databases
• Post-market databases
• Standards
• Registries
• Clinical trial registries
The literature review identifies
66
potential sources of clinical
data that are relevant to the
device under evaluation. These
are data that relate either to
the device under evaluation
or to the equivalent device
(if equivalence is claimed).
The updated MDR requires
establishing current knowledge
or the state of the art. For
example, if the device under
evaluation is implanted using
one type of procedure and
there are three alternative
procedures, the review
should adequately assess
the alternative procedures.
The summary of the CER
should include an analysis of
why the product is relevant
and competitive from a risk/
benefit ratio to the alternative
procedures.
A literature review plan should
outline databases to be
searched, search terms, and
inclusion and exclusion criteria.
More than one database
is necessary. When using
several databases, an overlap
SOCRA SOURCE © May 2023
in the data can demonstrate
consistency in the results. The
inclusion and exclusion criteria
must be justified. The outcome
of the searches must be shown,
and exclusion of articles must
be justified. The literature
review must be reproducible by
the reviewing organization.
Once all of the data have been
identified, a critical appraisal
is needed. This provides the
opportunity to make informed
decisions about the quality of
the research evidence. For each
article, evaluate the validity
of the results, the limitations,
the applicability of the results,
and whether there is bias. In
determining whether the results
are valid, the following key
questions should be answered:
• Is there a sound
methodology to answer the
question?
• Have the researchers
adhered to the
methodology?
• Is there bias?