Medical Innovation Exchange

RC – EU MDR and IVDR

The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR

The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR     Equivalence strategies can be used to efficiently demonstrate the safety of a medical device, limiting the need for new studies and testing. Given the level of investment that may be needed to achieve compliance with the EU Medical Device Regulation (MDR), leveraging equivalence may …

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State-of-the-Art: Unpacking MDR’s Evolving Requirements

State-of-the-Art: Unpacking MDR’s Evolving Requirements     The Oxford Dictionary defines “state-of-the-art” as something that belongs or relates to the most recent stage of technological development. It is something that incorporates the newest technology, ideas and features. In short, state-of-the-art means the most advanced, sophisticated, innovative version of a thing. The European Union’s Medical Device Regulation …

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