A U.K. newspaper accuses some of the largely private entities that handle medical device approvals in the European Union of crossing the line by competing for business and offering regulatory advice on how to package products made elsewhere as locally manufactured. They did so with an all-metal hip implant used as part of a sting.
The Telegraph conducted the sting regarding "notified bodies," which issue CE marking for medical devices and determining whether or not they meet various regulatory standards. And the news organization makes some pretty strong accusations, based on responses given to reporters who presented themselves as representing a Chinese device manufacturer.
In one case, the article alleges that an executive with SGS in Budapest--one of 70 notified bodies in the EU that handle CE marking--improperly offered advice on how to market a metal-on-metal hip implant made in China to unsuspecting EU patients as from a European Country. This would be by way of a company in Hungary that could represent the product or create a separate company based in the EU to market it. The idea, according to the story, was that such a product would be more marketable (aside from the fact that all-metal hips are largely discredited as having numerous health risks).
Another notified body--EVPU--allegedly advised an undercover reporter how easy it was to establish a British corporate "representative" for the company and then label the product as being made in the U.S. Many companies do this, the EVPU representative said, adding that under the rules, such a product would be legally considered as British-made. Similar pitches came from an ITC representative, the story claims. Even in Turkey, which is not part of the European Union, but is allowed to approve medical devices for sale in its market via the CE marking, two notified bodies are quoted as telling undercover reporters they'd loosen requirements to help speed up the approval process.
An EVPU official declined to comment to The Telegraph. An ITC spokesman asserted that the company complied with the law. An SGS spokesman, similarly, is quoted as telling the newspaper that the technological review process would have flagged the problems with an all-metal hip and ultimately left it without a CE marking. That spokesman added it was proper to talk about "own-brand labeling" as part of the process of understanding clients' regulatory needs.
The story is disturbing because it highlights flaws with the European device regulatory system, where unlike with the FDA in the U.S., private entities like the notified bodies are involved in the regulatory process. Private companies need to make money, after all, and the article suggests that some notified bodies are skirting the rules to obtain clients to which they'd grant a CE marking. That very system, of course, has come under fire in recent months. A major scandal erupted last year involving faulty breast implants approved for use in the European Union. Hysteria also continues regarding the widespread use of metal-on-metal hips in the European Union (and the U.S.), with questions remaining about an approval process that allowed them to reach the marketplace.
- read The Telegraph story