February 2024 SOCRA Source Journal - Journal - Page 73
Table 10 highlights key details
for a CER in China, which
has three degrees of clinical
evidence.
The first is that if it is a Class I
device or a Class II device and
is in the exemptions list, the
device manufacturer can submit
a simplified CER. About 1000
devices are common and well
known enough to not require a
direct clinical trial. The second
degree of clinical evidence is
a regular CER that is based on
equivalence. The device must
be approved in China, and
equivalence must be shown
in an extensive table and with
sufficient data to show that the
product is safe and effective. A
Clinical Study Report, based on
a direct clinical trial in China,
is the third degree of clinical
evidence.
Unlike the continual updates
required by the EU and
Australia, in China, the CER
only has to be updated upon
approval, indication expansion,
or changes. No periodic
updates are necessary. A
Chinese literature review is
required, with a focus on a
Chinese patient set search.
The recently introduced MDR
requirements for a clinical
evaluation plan, state-of-theart current knowledge, and
post-marketing clinical followup data are not required
in China. Demonstrating
equivalence requires that the
product is approved in China
and submission of a 16-point
comparison table addressing
the similarities and differences.
CONCLUSION
Developing a CER is something
of an art. Very often, the
outcome of the CER can be
swayed by the interest of the
company. For example, the
device manufacturer may say
that the benefits of the device
outweigh the risks; however, the
device is later recalled.
The need for post-market
surveillance and reporting is
growing and requirements are
increasing. The MDR requires
updating the CER as often as
necessary based on the postmarket data. Maintaining the
CER and corresponding files
requires a planned and crossfunctional approach by the
commercialization team.
Device manufacturers should
consider the CER an actionfilled opportunity. If the clinical
evaluation determines that the
risk/benefit ratio is affected,
consider generating more
clinical evidence or making
product improvements. The
device manufacturer should
not simply try to justify that the
benefits outweigh the risks.
If the CER outlines new or
other risks that have not
been addressed, the device
manufacturer should update
the risk management plan.
If new contraindications in
the literature are found when
working on the CER, the
instructions for use of the device
should be updated. If the CER
shows that some claims cannot
be supported, the device
manufacturer should consider
removing the claim or initiating
a clinical evaluation.
The CER is a central document
for regulatory submissions. In
Australia, the TGA will request
a CER even if the product is
approved in Europe. Doing a
critical appraisal of both direct
and indirect data is key in the
CER. The CER is more than
a presentation of data. The
data must be summarized and
conclusions about the data must
be made.
SOCRA SOURCE © May 2023
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