Episode Details

This is the audio-only version of RQM+ Live! #31, originally recorded March 25, 2021.

In connection with biological equivalence, the MDR states, “the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables.”

The intent behind using an equivalence strategy in the EU is to leverage the clinical data from the equivalent device via an assessment of risks arising out of any potential similarities or differences that may have an impact of the established safety/performance profile of the equivalent device.

Simple right?  Well actually, no.  This has been a big source of confusion for manufacturers in understanding what equivalence really is and having a consistent approach to presenting it in technical documentation.

Join us for an engaging discussion on practical solutions to establishing successful biological equivalence rationales. We'll cover the following and more:

Are any material differences in biological equivalence acceptable? The MDR says the materials have to be the "same".  We'll discuss real life examples. The MDR says materials have to be the same.  The MDCG guidance expands on what is acceptable.   How do we leverage this window effectively? How do we leverage EN ISO 10993 test results in support of biological equivalence, beyond mere biological safety evaluation? Is the approach for demonstrating biological equivalence different for Class II and Class III devices?

This esteemed panel is comprised of former notified body leaders and regulatory experts in their fourth year of developing and implementing biological equivalence strategies under the MDR.


Amie Smirthwaite, Ph.D. - Global VP, Clinical Regulatory Services Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services Jon Gimbel, Ph.D. - Executive Director, Regulatory and Quality Consulting Services Celeste Maksim, Ph.D. RAC - Senior Manager, PMS and PMCF Services Melissa DeHass - Senior Regulatory Specialist


About RQM+

RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

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