Sunday, November 11, 2012

The truth behind “made in Europe” labels on medical devices (2 of 3)

Medical Device Regulation


BMJ2012;345doi: 24 October 2012)
Cite this as:BMJ2012;345:e7193
In the second part of the BMJ’s joint investigation with the Daily Telegraph, Deborah Cohen shows how notified bodies are advising non-EU implant manufacturers to bend the rules
For the executive from the Hungarian firm authorised to approve medical devices for the European market, the brochure outlining a proposal for a new metal-on-metal total hip implant should have perhaps raised concern.

But, instead, Anna Szabo, an executive at SGS in Budapest, offered advice on how to market the product and make it more appealing to purchasers.

Although the implant would still need approval, Szabo said: “What we suggest is that you make a certification so that, on the product itself, the label would be from a European country and therefore the Chinese producer will not be on the packaging.”

“Why is that a good idea?” asked an undercover reporter posing as a potentially lucrative client from a Chinese firm, Changi. “This is better from a marketing point of view,” Szabo replied.
She then explained that SGS could find someone in Hungary to represent the Chinese company. “The point would be on the packaging of the things [it] is much better if you have a European kind of origin country,” she said.

“It’s much more of a paperwork kind of thing,” she added.

The executive then assured the reporters that the Chinese company would not have to set up a company in Europe.

“Either we find somebody or you can do it on your own. That’s no problem,” she said.
The advice was offered in a follow-up telephone call after a meeting with Szabo in Budapest.
A spokesman for SGS said that the company was “confident that the technical review process would have highlighted the dangerous nature of the products described and SGS would have declined to issue a proposal.”

The spokesman said it discussed European labelling because it was “the duty of the notified body to understand the basis and requirements of potential clients and to advise them on the features of each option.”

SGS is one of over 70 notified bodies in the EU that are able to assess medical devices and award a CE certificate, which allows devices to be sold across Europe.

In an increasingly cut throat business, the notified bodies—which are supposed to safeguard patients—seem to be competing to win business from medical device companies. They are not supposed to offer advice to companies seeking market access, but some notified bodies charged with issuing CE certificates appear to take a relaxed view of the rules.\

It is difficult to find out where products have been awarded CE certification within the EU, but the issue of devices being “relabelled” came up repeatedly, adding further opacity to the system.
At EVPU, a notified body in Slovakia, the company’s representatives explained that it was straightforward to establish a “representative” in Britain and then label the products as British made, a process known as own brand labelling.

“You can make some company in England and then sell this product [as] produced in England,” said Peter Luley, one of EVPU’s employees. “It works, and it is normally done by many company.”
The representatives said that, under these rules, the manufacturer is seen as being British. They said that this was “standard procedure.”

As one EVPU representative said: “It’s very hard to find the products that [are] from India, because [of] own brand labelling. And we have lots of customers from the UK which buy the product from India manufacturer and put on their own label.”

An undercover reporter asked: “Their own name on it?” to which the representative replied: “He is the legal manufacturer . . . . This is allowed by the medical directive [the European Union rules].”
The EVPU executives admitted this made the approval procedure opaque. “So it makes some problem to find [the] original manufacturer of some devices,” one said.

The representative then added that own brand labelling was used for Indian manufacturers or for the distribution of products to the European Union because, “if you see on some products made in India, made in China, [the reaction is] urgh.” She said that it was better for the label to say made in the “UK, Germany, or Switzerland.”

EVPU declined to comment on this advice.

At ITC, a notified body in the Czech Republic, a representative said Asian and Indian companies liked operating in this way because consumers believed the products were manufactured in Europe. A spokesman for ITC said: “As an EU notified body we comply in full accordance with the law.”


Money making and failure

An executive at a Turkish regulatory body has admitted that the process for assessing medical devices for market access in Europe is a “money making business.”

Teoman Alpay, an executive at Kalitest, also suggested that some notified bodies loosen the “requirements” for certifying an implant by implementing a less rigorous approach towards European requirements.

Turkey has been allowed to award CE certificates to medical devices for sale across the Europe Union since 2009.

In a meeting with representatives from a fake Chinese company seeking approval for a metal-on-metal total hip prosthesis, Alpay said, “If you want to be a little bit further among your competitors, you should just decrease your requirements and in this business, decreasing the requirements means not fulfilling the requirements of MDD [EU medical devices directive].”

Alpay said that it was true that some notified bodies did not comply, but they were not based in Turkey.

At another of the notified bodies in Turkey, called Alberk, which is located above a garage on the outskirts of Istanbul, another executive also indicated that he was prepared to overlook “minor” problems when considering a product for a licence.

Kadil Tarakci, said: “Small points is nothing for us because everyone has [omissions]. Everybody—trust me, everybody.”

Both firms said that the executives who made the comments had since left the companies.
However, the comments from the two Turkish firms appear to highlight a problem with the system where competing notified bodies market their services to potential clients.

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