On Feb. 9, 2012, the European Commission (EC) called on the governments of the 27 EU countries to take immediate action to protect patients in the EU by tightening controls on implantable and other high-risk medical devices. This will intensify regulatory scrutiny and businesses selling such devices in the EU should be prepared.
The call was made by European Health and Consumer Policy Commissioner John Dalli, subsequent to huge public concern in the EU following the PIP breast implant incident. Commissioner Dalli has requested action, under the current legislative framework, in a number of areas relating to high-risk devices, including greater use of unannounced inspections (“dawn raids”), spot checks and testing of products; better reporting of adverse events; and support for the development of tools to ensure both the traceability and the long-term monitoring of devices.
Revised EU medical devices legislation is scheduled for adoption before the summer and it is clear that it will be strengthened generally in the areas of market surveillance, vigilance, traceability and the operation of the bodies that assess high-risk devices in the EU. However, this legislation will not take effect immediately and therefore Commissioner Dalli has acted to tighten controls now.
For more information, see the EC’s medical devices website.