RQM+ Live! is a biweekly and interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer audience questions. Every episode is added to our podcast, too.
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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.
Panelists:
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
Bring your questions and join the discussion!
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