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.
