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
For more information, see the EC’s
medical devices website.