Spotchecks for medical device manufacturers

Published: 21-Feb-2012

EU health chief demands improvements to regulatory system after PIP scare

Just weeks after BBH revealed widespread calls for improvements to the regulatory system for medical devices, the EU’s health chief has called for spot checks on manufacturing facilities.

Speaking to the media in Brussels, EU health and consumer affairs chief, John Dalli, said the recent PIP breast implant scare had highlighted an urgent need for reform of the CE Marking system currently used to approve devices for medical use.

The PIP scare followed the revelation that the manufacturer, which had received approval for the product from French regulators in 2000, had switched to using industrial-grade silicon that was not passed for use on humans.

Dalli said the scandal showed the current approval system was seriously flawed and he is calling for spot checks on products and manufacturing centres to be introduced.

In the UK, devices are approved by the Medicines and Healthcare products Regulatory Agency (MHRA), although the actual assessments are carried out by 70 ‘Notified Bodies’ across Europe, which are responsible for issuing the CE Mark certificates.

“I am deeply concerned about the potential health impact for the many women who received faulty silicone breast implants,” Dalli said. “The consequences for health are still uncertain.”

He has now written to all 27 health ministers involved and urged them to make full use of existing laws to keep a check on products and manufacturers.

And he has called for an urgent review into the 80-or-so regulatory agencies responsible for approving the most high-risk medical devices in Europe, most of which are private firms.

“I have asked my colleagues in the member states for their personal commitment to implementing these actions as a matter of priority,” he said.

“I know we all subscribe to the need to put patients first and to restore trust in our regulatory system.”

Responding to his comments, Eucomed, an industry body representing 22,500 MedTech companies across Europe, said it supported the strengthening of current laws.

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