Medical Design Briefs - January 2022 - 4

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I NS I DE STORY
Eurofins Medical Device Testing offers biocompatibility expertise and experienced testing to
ensure rapid turnaround times with the highest level of service, and most advanced technologies.
MDB spoke to Eurofins' director of biocompatibility, Geoffrey Moodie, PhD, who answers some
commonly asked biocompatibility questions.
MDB: Do device manufacturers always
need Biological Risk Evaluation documentation?
Geoffrey
Moodie, PhD
Director of
Biocompatibility,
Eurofins
Geoffrey Moodie: Yes. These documents
should be thought of as the collected
evidence that the biological risks
have been appropriately evaluated for
your device. The Biological Evaluation
Plan and Report are described in ISO
10993-1.
MDB: Must a Biological Evaluation Plan/Report be written
by an accredited laboratory, or can a company's quality
department write these documents?
Moodie: The ISO 10993-1 introduction calls for experts with
appropriate experience and/or training to evaluate a device.
While it does not call for a particular accreditation, you may
need to show that the person(s) involved have the necessary
expertise.
MDB: What if a device manufacturer already has biological
safety information for a device?
Moodie: The Biological Evaluation Plan should take into
account all of this information. It may be that, upon the evaluation
performed as part of the plan, there is already sufficient
information to address biological risk and no further
testing is needed. However, it will be important to have this
document to demonstrate that biological risks were appropriately
evaluated.
MDB: Is a Toxicological Risk Assessment always needed
after E&L testing?
Moodie: A Toxicological Risk Assessment should be planned following
E&L Testing. While there may be some instances where
it is not needed (for example, if no compounds are extracted),
these tend to be very infrequent exceptions. Even if you consider
your raw material to be " clean, " there are often processing
residues introduced into and onto your final product.
MDB: How do you handle a substance with limited or no toxicological
data?
Moodie: Our toxicologists use a variety of techniques to evaluate
the potential toxicity of such compounds by looking at better
characterized compounds with similarities in structure,
using computational techniques, and consideration of appropriate
safety factors.
MDB: Can any of a device's in vivo studies be conducted
non-GLP?
Moodie: GLP is the expectation for in vitro and in vivo data
used to support the safety of a device. Use of non-GLP data
for this purpose will likely require a careful justification as to
why GLP was not an option. However, not all studies need to
be GLP. For example, basic exploratory studies carried out to
determine whether a new concept has any potential utility
may not require GLP.
MDB: How do we handle testing of a device that is made up
of patient and nonpatient contacting portions?
Moodie: When performing extractions for biocompatibility, testing
it can be important to ensure that you isolate any components
that will not have patient exposure as these may lead to
false positives. This may be done by removing the noncontacting
materials or " masking " noncontacting components so that
the extraction fluid cannot reach them. Note that the device
tested should otherwise be as close as possible to the final finished
product, and any differences between the test sample and
final finished product documented and justified.
MDB: What if a lab says they need to cut a device that is too
large to test. Should there be concern?
Moodie: You should pay attention to whether or not cutting will
result in materials being exposed that would otherwise not
come into direct or indirect contact with the patient/user.
Discuss this with the lab to ensure the device is sectioned in a
way that the results will reflect the materials to which the
patient/user are actually exposed.
MDB: Why should a Biological Evaluation Report be considered
a living document?
Moodie: Changes in materials, manufacturing processes, packaging,
sterilization, shelf-life, storage/transport, intended use,
or reports of adverse events are all reasonable to expect within
the device lifecycle. These changes will need to be evaluated for
their impact on biocompatibility and the Biological Evaluation
Report updated accordingly.
To find out more about Eurofins, visit www.eurofins.com/
Medical-Device.
4
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Medical Design Briefs, January 2022
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Medical Design Briefs - January 2022

Table of Contents for the Digital Edition of Medical Design Briefs - January 2022

Medical Design Briefs - January 2022 - Intro
Medical Design Briefs - January 2022 - Sponsor
Medical Design Briefs - January 2022 - Cov1a
Medical Design Briefs - January 2022 - Cov1b
Medical Design Briefs - January 2022 - Cov1
Medical Design Briefs - January 2022 - Cov2
Medical Design Briefs - January 2022 - 1
Medical Design Briefs - January 2022 - 2
Medical Design Briefs - January 2022 - 3
Medical Design Briefs - January 2022 - 4
Medical Design Briefs - January 2022 - 5
Medical Design Briefs - January 2022 - 6
Medical Design Briefs - January 2022 - 7
Medical Design Briefs - January 2022 - 8
Medical Design Briefs - January 2022 - 9
Medical Design Briefs - January 2022 - 10
Medical Design Briefs - January 2022 - 11
Medical Design Briefs - January 2022 - 12
Medical Design Briefs - January 2022 - 13
Medical Design Briefs - January 2022 - 14
Medical Design Briefs - January 2022 - 15
Medical Design Briefs - January 2022 - 16
Medical Design Briefs - January 2022 - 17
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Medical Design Briefs - January 2022 - 19
Medical Design Briefs - January 2022 - 20
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Medical Design Briefs - January 2022 - 26
Medical Design Briefs - January 2022 - 27
Medical Design Briefs - January 2022 - 28
Medical Design Briefs - January 2022 - 29
Medical Design Briefs - January 2022 - 30
Medical Design Briefs - January 2022 - 31
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Medical Design Briefs - January 2022 - 37
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Medical Design Briefs - January 2022 - 39
Medical Design Briefs - January 2022 - 40
Medical Design Briefs - January 2022 - Cov3
Medical Design Briefs - January 2022 - Cov4
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