Medical devices - The forthcoming revision of the EU legislation on medical devices

The recent PIP breast implants scandal and emerging technologies have challenged the current legislative framework and highlighted loopholes which put consumers’ health at risk.

The forthcoming EU legislation on medical devices should focus on increasing patient safety and consumer confidence by:

• Increasing quality and safety standards;
• Strengthening pre-market assessment;
• Ensuring consistency among the notified bodies;
• Better regulating border line products, aesthetic products and self-testing devices;
• Reinforcing market surveillance;
• Providing consumers with better information;
• Improving transparency, coordination and enforcement;
• Designing a legal framework which meets the needs of tomorrow.