Abstract :
Recent scandals have made the EU think again about its medical device regulation. Legislation is afoot to tighten up the rules as to what medical devices - from pacemakers to breast implants and artificial hips - are allowed on to the European market. But are European lawmakers about to go too far? Could we end up with the sclerotic approval system they have in the US, where products take years to get to market? The medical device manufacturers and some experts seem to think so.
