February 2024 SOCRA Source Journal - Journal - Page 71
TABLE 8:
THERAPEUTIC GOODS ADMINISTRATION CER REQUIREMENTS
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Legislative basis
Clinical evidence:
◦ Key definitions and concepts
◦ Clinical data
CER:
◦ Format
◦ Supporting documents
◦ Common errors in the CER
Demonstrating substantial equivalence:
◦ Clinical evidence requirements
◦ Predicate and similar marketed devices
◦ Substantial equivalence
marketing clinical follow-up
data or a safety and efficacy
summary, is another common
issue. Sometimes, there is a lack
of sufficient clinical evidence for
previously approved products.
Before the MDR, many
products were acceptable with
loosely defined equivalence
without clinical evidence. Now,
clinical evidence is required.
Device manufacturers must
think creatively to determine
whether the post-marketing
data is sufficient. It may be
necessary to commit in the CER
to conduct a post-marketing
clinical trial.
PREPARING A CER FOR
AUSTRALIA
Australia is a relatively small
market; however, its regulatory
framework is very mature. The
TGA has a definition of clinical
evidence, which includes the
literature review and clinical
investigation data, and clinical
evidence guidance for medical
devices, which is similar to
MEDDEV. Device manufacturers
should review the clinical
evidence guidance before
submitting a CER in Australia.
Table 8 highlights TGA CER
requirements, which have a
legislative basis. For clinical
evidence, definitions, concepts,
and clinical data are described.
The format, supporting
documents, and common errors
in the CER are also described.
More often than not, CERs that
are compliant with the MDR
have the right format; however,
there are some differences
between a CER for Europe and
one for Australia. The clinical
evidence guidance also has a
section on how to demonstrate
substantial equivalence.
Requirements for the medical
reviewer differ in the EU and in
Australia. In the EU, the MDR
states that the medical reviewer
can be a general practice
physician or someone who is
a regulatory professional now
and has not been practicing for
many years. The TGA requires
the medical reviewer to have
relevant medical qualifications
and direct clinical experience
in the use of the device or the
device type. For an emergency
product that is used in an
ambulance, for example, a first
responder could be sufficient
as a clinical expert. This
requirement, however, excludes
generalists who may not have
any experience treating the
patients who will receive the
device under evaluation.
Attachments to the CER are
required for specific high-risk
devices:
• Total and partial joint
prostheses
• Cardiovascular devices
to promote patency or
functional flow
• Electrical impulse generators
• Heart valve replacement
using a prosthetic valve
• Supportive devices (meshes,
patches, and tissue
adhesives)
• Demonstrating the safety of
implantable medical devices
in the magnetic resonance
environment
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