EU medicines head urges tougher implant rules

By REUTERS
January 6, 2012 17:49

LONDON - The new head of Europe's drugs watchdog said on Friday there was an acute need to tighten regulations on medical devices, adding to pressure for radical change in the wake of a global scandal over French-made breast implants.

"I see an urgent need to regulate devices at the same level of science and attention as with drugs," Guido Rasi, executive director of the European Medicines Agency (EMA), told Reuters.

Medical devices are regulated in the European Union not by the EMA, but under the "CE mark" scheme, which is also used for household appliances such as electric toasters, a notably relaxed regime that has been criticized by doctors.

In contrast to prescription medicines, devices need only a simple quality certification before being sold to the public.


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