* 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 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
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.