In the EU, a device is considered to be equivalent if and only if it fulfills all the requirements of technical, clinical, and biological equivalence. Of these, biological equivalence tends to be the most nuanced and can be a confusing topic for medical device manufacturers—especially since regulators in different global regions don’t always take the same approach. Chemical characterization, which tends to get ignored—but is now a requirement per MDR, Annex II, section 6.1(b)—can help make claiming biological equivalence more feasible when “similarities/differences” exist.
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