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Biological Equivalency: When is “same” the same?

Biological Equivalency: When is “same” the same?

BiocompCHATibility vor 4 Jahren

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45:16

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

In this episode, our hosts are joined by NAMSA Toxicologist,
Michelle Kelly, to discuss the ever-elusive biological
equivalency claim. The discussion focuses on how to maintain the
balance of the risk and benefit of a medical device without
stalling innovation. We also explore equivalency and how it
is not only a key concept to the risk analysis but also a
challenging concept to prove.

“This is often a controversial topic.” – Sheri Krajewski

“You not only have to think about equivalency per 10993-1, but
also think about it as one aspect of equivalency that is sitting
in the MDR.” – Don Pohl

“Equivalency is one of the key principles that sits in 10993-1.”
– Don Pohl

“To think of equivalence as a concept rather than an equation is
the best thing to do.” – Michelle Kelly

“We have that word “same” sneaking up on us. I can see that being
interpreted differently by reviewers and regulators.” – Don Pohl

“When we developed it [Annex C of 10993-18], we were trying to
define toxicological equivalence to help out the working group
writing 10993-17.” – Michelle Kelly

Discussion points include:

      Equivalence in the 10993
Series, including ISO 10993-18 Annex C

      Equivalence under the MDR

      Variances in the EU from
one Notified Body to another

      Challenges with
demonstrating and establishing overall MDR equivalence

      The concept of “same” and
how it is interpreted by regulators