BRUSSELS/LONDON (Reuters) - The European Union said it wants tougher rules governing the safety and monitoring of medical devices after weak EU regulations were partly blamed for a global scandal over French-made breast implants.
The plans will affect a huge range of products, from contact lenses to pacemakers to pregnancy testing kits to high-tech medical equipment such as life support machines.
Major manufacturers of medical devices include Johnson & Johnson, Medtronic, Boston Scientific, Abbott Laboratories, Allergan and Smith & Nephew.
Investigations last year showed that hundreds of thousands of women around the world had been implanted with substandard silicone products 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 controls on medical devices, which are currently overseen by an ad hoc network of up to 80 national assessment agencies.
“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 as he outlined draft proposals for the new rules on Wednesday
The proposals take into account lessons from the PIP implant scandal AND include a scrutiny panel which would monitor the national agencies’ assessments.
“They (the panel) would have the possibility to pick out medical devices on certain risk-based criteria to decide whether to go into an in-depth analysis of the processes,” Dalli told reporters at a news conference.
Industry body Eucomed, which represents about 22,500 medical technology companies in Europe, said it was unhappy with the proposal for the new scrutiny panel procedure, which it said would “hamper innovation” whilst providing no extra safety nets for patients.
“The current regulatory framework has provided a high level of safety for patients in Europe without delaying them access to life-saving medical technologies,” Serge Bernasconi, Eucomed’s chief executive, said in a statement.
“Let’s not unnecessarily push away Europe’s strong innovation and research capabilities to other continents at a time when they are urgently needed.”
European Consumer Organisation (BEUC) argued, on the other hand, that the plans fall short of increasing quality and safety standards and said medical device regulations should be beefed up to levels similar to those required for pharmaceuticals.
“It is unacceptable that consumers are afforded different protection levels depending whether they have an artificial heart valve or take medicine for diabetes,” said Monique Goyens, head of BEUC.
She noted that if a there is a problem with a drug, patients can stop taking them, but if an implanted device is problematic, patients may face invasive and risky surgery to have it removed.
Among other main changes proposed is 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.
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.
The legislation must be jointly approved by EU governments and lawmakers, which could take up to two years.
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Editing by James Jukwey and Hans-Juergen Peters