Medical devices are instruments, software or implants which are used for diagnosis, monitoring, treatment or replacement due to injury or disability. They cover a vast spectrum of products ranging from low-risk products such as corrective glasses, sticking plasters, etc. to high-risk products such as pacemakers and hip implants.
The existing regulatory framework for medical devices dates back to 1990 and 1993 and needs to be updated substantially to keep pace with technological and scientific progress, and to harmonise the way the rules are applied. Recent scandals such as fraudulent silicone breast implants and problems with certain metal-on-metal hip-joint replacements have shown that the approval system in place is not appropriate for high-risk devices. Under the current regime, notified bodies assess the performance and safety of medical devices, but this process is not sufficiently transparent and neither are the fees they charge to manufacturers. The S&D Group is pressing for improved patient safety and better protection of EU citizens from defective medical devices through a more effective and efficient system for granting market access.