The biggest difference is going to be how EU allows you to use a “similar,” or reference device, in your approval process. In the U.S., your predicate device can be a competitor’s device. Typically, the only information you will have on that device is going to be what you can gather on the Internet. In Europe, with the new MDR, utilization of a “similar” device in your application is going to require you to have access to technical design and performance specifications. This means that unless your competition is willing to share these details, your similar device is going to have to be a device already in your product portfolio. For large companies already in the market, this will not impact them. However it will make it very difficult, if not impossible, for start-up companies with novel technology to gain EU approval.
