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On March 15, 2023, the European Parliament amended the original Medical Device Regulation (MDR) to lengthen the compliance period for certain medical devices and in vitro diagnostic devices. The move provides device manufacturers with additional time to prepare their products for market and offers a buffer for those trying to navigate the EU’s “state-of-the-art” designation. The amended timeline proposes staggering submission deadlines to prioritize submissions based on patient risk.
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.
Mark Cabonce, principal toxicologist, Sandi Schaible, senior director of analytical chemistry and regulatory toxicology, and Dr Sherry Parker, senior director of regulatory toxicology, WuXi AppTec advise how medical device manufacturers can best navigate the recent updates of ISO 10993-18:2020.
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