The past few years have seen regulators on both sides of the Atlantic change their approach to medtech. The biggest changes have happened in the EU, where MDR and the In Vitro Diagnostic Regulation are redefining what it takes to bring products to market in the region. At the same time, FDA has set the target of making the U.S. the priority market for developers of novel devices.
In its most recent assessment, FDA found almost two-third of manufacturers of novel technology devices plan to bring their products to the U.S. first or in parallel with other major markets. The BCG report adds to evidence that FDA is on course to achieve its objective.
