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.
REGISTER NOW and join us for an engaging discussion on practical solutions to establishing successful biological equivalence rationales. We'll cover the following and more:
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.
Bring your questions and join the discussion!