Sunday, November 11, 2012

Manufacturers offered helping hand with EU approval (3 of 3)

Medical Device Regulation


BMJ2012;345doi: 25 October 2012)
Cite this as:BMJ2012;345:e7225
In the third part of the joint BMJ and Daily Telegraph investigation into regulation of medical devices, Deborah Cohen describes how the quest for an EU licence for a fictitious hip implant involved travelling to South Korea
The shiny office block in a business district of Seoul, South Korea, is not the most obvious place to find an organisation offering to certify a medical product for use in patients across Europe. But, earlier this month, in a meeting on the 14th floor of the building, undercover reporters posing as representatives from a Chinese medical device company were discussing such a licence.

As the air conditioning hummed in the background, the four smartly dressed Korean men from ITC in Asia began their presentation—in reality, a sales pitch about how they would be able to effectively guarantee a metal-on-metal hip prosthesis access to the European market.

The president of the company, Dr Gong, said that the firm was the “best in the world” and the “exclusive partner” of a notified body in the Czech Republic. As part of their relationship with the agency they did “all the results” for Asian companies that applied for the CE certification required to sell products within the European Union.

With over 1000 clients, they could offer a “competitive” fee. “We only focus on how to help our clients,” said one of the employees as he flicked through the Power Point presentation.

The businessmen said the company could offer a “one stop shop” and help clients “increase profit.”
The path to the meeting in Seoul had begun several months earlier during a joint investigation by the BMJ and the Daily Telegraph into the regulation of hip implants and other medical devices in Europe.

Undercover reporters had travelled to eastern European countries including Hungary, Slovakia, and the Czech Republic to meet representatives of notified bodies—the organisations charged with issuing licences—to discuss certifying a fake, potentially dangerous implant.

As we have exposed this week, several notified bodies were prepared to consider offering such certificates.

But during meetings in Slovakia and the Czech Republic another loophole emerged. Two notified bodies—3eC in Bratislava and ITC in Zlin—said that they had Asian “representatives” who could deal with applications outside the European Union.

Under European legislation, the notified bodies are only supposed to assess whether applications for medical devices meet the required standard. They are not supposed to offer consultancy services on how to receive the certification.

However, on arriving in the offices of ITC Cert in Seoul, the undercover journalists were offered the services of three companies. One would assess the technical submission for a CE certificate; another would offer consultancy; and a third could help with marketing the device and distribution across Europe. Conveniently, the three firms appeared to share many members of staff.

Gong said the firms were “legally separate” and “independent.” However, one of the company’s employees later claimed this was not the case.

“He [Gong] said the company is—the companies are separate . . . but actually the working people are the same,” said Kenneth Lee.

The cost of the consultancy service was an extra $12 000 (£7500; $9200) on top of the $17 000 certification fee. The quote of $17 000 was four times more than that suggested by the company’s office in the Czech Republic.

For the high fees, the ITC office in South Korea said that clients enjoyed a high success rate. When a reporter asked the general manager, Dong-in Shin, about the company’s success rate during a telephone call before the meeting he said that no case was rejected.
Lee also said that the European system was “easier” than the regulatory procedure in the United States because the notified bodies were paid by the manufacturer and therefore wanted an application to succeed.

He said: “We [the notified body] worry about starting project, but the FDA [US Food and Drug Administration] they don’t care.” He said that the officers of the US regulator would “kill” the licence application if the manufacturer didn’t have any evidence but that for “CE, actually the auditor individual they are trying to finish the project, not kill.”

When the reporter asked if notified bodies wanted to help the manufacturer, Lee replied “Oh, yes, yes, yes.”

During the meeting at the company’s office in Seoul, representatives of the company reinforced that they could help clients “increase profit.”

The sales pitch was similar at a “partner” of the Slovakian notified body 3eC. The undercover reporters telephoned Vidduyt Bera from BS Certification Services, which has its headquarters in Hong Kong, in September to find out more about how he could help their application. When they asked Bera how many of his clients obtained CE certification for medical devices, he claimed he was 100% successful.

“Because of 19 years of experience in this field, its success rate [is] 100% when we recommend it [the application] to notified body.”

Bera said he would charge the same as the regulator in Slovakia—thousands of euros.

“I will be reviewing the technical files first . . . . Once I approve the file and I also recommend that already successful, then this entire document goes to Mr Jan Petrik in Slovakia,” said Bera. He said that he would pay the regulator himself and that the manufacturer did not need to pay anything to the notified body in Slovakia.

Bera said that the “advantage” of using his services instead of dealing with the notified body directly was that the client “will come to know a lot of things in advance before it is done a final review” and that he was “in a position to support the client in many ways because the entire review before the file goes to notified body . . . is taken care of by me. So most of the time it happens that when I approve the file and everything is completed [there are] high chances that the file will pass in one attempt.”
However, although he would write a report for the client outlining “what is required, what is missing,” as well as “what’s right and what needs to be changed,” he would not officially be able to act as a paid consultant.

There is now growing pressure on the British authorities to put their own checks into the system amid fears that hundreds of medical devices that have passed through the offices in Asia are now being used on unsuspecting patients across Europe.

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