Is speed of approval valued over risk?

In support of centralized approvals: The EU system for approving medical devices has come under criticism because of the number of approved devices which have turned out to be dangerous. In the United States, sufficient valid scientific evidence in humans is required which shows high-risk devices are both safe and effective. In Europe, however, approval of medical devices is conducted by private for-profit companies and based on much more limited evidence. Often there are no significant studies in humans required to show these devices are safe. There is no absolute requirement that medical devices provide an actual treatment benefit to patients.

Change is needed in Europe: I would say definitely yes, it is desirable for Europe to have a centralized regulatory approval process based on scientific evidence. To have a more thorough evaluation, to have a more equal deliberation process, and to have the knowledge in one office would be good instead of how it is today where there are around 80 to 90 different bureaus involved in device clearance.

Click here to read the full Point/Counter article in the October Issue of Orthopaedics Today Europe.