Towards meaningful change
UPDATE: In a plenary session on 22 October, Members of European Parliament voted against the introduction of a US-style centralised pre-marketing authorisation system for medical devices in Europe. This vote paves the way for further discussion with EU Member States which, together with the Parliament must agree on a final regulatory framework for medical devices.
Today in Europe people have access to life-saving medical devices 3 to 5 years sooner than other parts of the world. The reason for this is Europe’s unique approval system, which has proven to be as safe as other systems in the world and is saving and enhancing many lives every day.
Many groups and experts in Europe, including doctors, patients and industry, agree that the current European system needs to be improved to cope with new medical technologies and innovations. But let’s keep what works and fix what needs to be improved instead of radically changing the system.