The Challenges of Demonstrating Biological Equivalence

In the European Union (EU), a device is considered equivalent if it fulfills all the requirements of technical, clinical, and biological equivalence. Of these, demonstrating biological equivalence tends to be the toughest aspect of the overall equivalence argument. Biological equivalence is a concept that allows medical device manufacturers to reduce or avoid animal testing for their products by demonstrating that they are biologically equivalent to another device that has already been tested and approved for the market. This concept assumes that if two devices have the same chemical composition, surface characteristics, and intended use, they will have the same biological response in the human body. Demonstrating biological equivalence, however, is not a simple task.