This is an interesting article. It also points out that a medical device is actually faster and less expensive than a medicinal product. But if the combination product has both a medical device and a medicinal component, that it is automatically considered a high risk and the notified body along with the competent authority evaluate the safety, quality, and usefulness the drug portion. Lastly, a key component that the EU will enforce more strictly any new regulations created while keeping the existing ones set in place since they are currently in use. Would this mean that the EU has the potential to be as highly regulated as the FDA and if not stricter?