Implant scandal sparks revamp of EU medical device rules
* Rules to tighten product approvals, safety checks
* Changes follow French breast implant safety scandal
* Plans must be approved by EU governments, lawmakers
BRUSSELS, Sept 26 (Reuters) - The European Union has proposed tougher rules on assessing the safety and monitoring the use of medical devices and implants, after weak EU regulations were partly blamed for a global scandal over French-made breast implants.
Investigations last year showed that hundreds of thousands of women around the world had been implanted with substandard silicone implants made by defunct French company Poly Implant Prothese (PIP), which safety regulators had failed to stop for more than a decade.
The scandal prompted calls for Europe to toughen its controls on medical devices, which are currently overseen by an ad hoc network of up to 80 national assessment agencies, most of which are private companies.
"Just a few months ago, everybody was shocked by the scandal involving fraudulent breast implants which affected tens of thousands of women in Europe and around the world," EU health commissioner John Dalli said in a statement on Wednesday to outline the draft rules.
The proposals take into account lessons from the PIP implant scandal, and will significantly tighten the authorisation process for medical devices before they are put on the market, the European Commission said.
Among the main changes will be an extension of the current legal definition of medical devices to include breast and other aesthetic implants.
Independent assessment agencies will be given greater powers to monitor device manufacturers, including unannounced factory inspections and regular product testing, while EU governments will be obliged to improve their supervision of the agencies.
"If this was happening in the market, the PIP scandal would have been detected many years before and eliminated," Dalli told a news conference.
Better product traceability systems will also be introduced so that people can be alerted more rapidly to safety concerns surrounding a particular device.
The European market for medical devices was estimated at 95 billion euros ($123 billion) in 2009, with products ranging from sticking plasters to high-tech miniature diagnostic implants and life support machines.
Major manufacturers of medical devices include Johnson & Johnson, Medtronic, Boston Scientific, Abbott Laboratories, Allergan and Smith & Nephew .
The legislation must be jointly approved by EU governments and lawmakers, which could take up to two years.