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