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Faulty medical implants investigation: ‘We can help you label it European so China is not on packaging’ – Telegraph.

Faulty medical implants investigation: ‘We can help you label it European so China is not on packaging’

Firm tells reporters posing as representatives of hip implant maker how to bend the law.

By Claire Newell and Holly Watt9:56PM BST 23 Oct 201219

For the female executive from the Hungarian firm which is authorised to approve medical devices throughout Europe, the brochure outlining a proposal for a new “metal-on-metal” hip implant should have rung alarm bells.

The two people purporting to be executives from a Chinese firm called “Changi” should politely have been told that such a product could be risky and certification might be a problem.

But Anna Szabo, an executive at SGS in Budapest, offered advice on how to “market” the questionable product to unsuspecting patients in Britain and elsewhere. While the product would still need approval, Ms Szabo said: “What we suggest is that you make a certification so that the, on the product itself, the label would be from a Hung- … European country and therefore the Chinese producer will not be on the packaging.”

“Why is that a good idea?” asked the person Ms Szabo thought was representing a potentially lucrative client from a Chinese firm, but was, in fact, an undercover reporter from The Daily Telegraph.

“This is better from a marketing point of view,” the SGS executive replied. Ms Szabo said they could find someone in Hungary to represent the Chinese company. “The point would be on the packaging of the things … 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 said.

The executive 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 Ms Szabo at an office block in Budapest.

SGS is one of over 70 notified bodies in the EU which are able to hand out the coveted CE marking — the official licence.

In an increasingly cut-throat business, the regulatory organisations which are supposed to safeguard patients, appear to be aggressively competing to win business from dozens of medical device companies. They are not supposed to offer consultancy to companies seeking regulatory approval, but some notified bodies charged with issuing licences appear to take a relaxed view towards the rules.

It is difficult to find out where products have been approved within the EU — and which may have been made abroad – but the issue of devices being “relabelled” came up repeatedly as The Daily Telegraph visited notified bodies in Europe.

At EVPU, a notified body in Slovakia, its representatives said it was easy to establish a “representative” in Britain and then label the products as British-made.

“You can make some company in England and then sell this product are produced in England,” said Peter Luley, an EVPU employee. “It works, 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 this was “standard procedure”.

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

An undercover reporter asks: “Their own name on it?” to which the representative replies: “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 original manufacturer of some devices,” one said.

The representative then added: “Used for Indian manufacturer or for the distribution of the product to European Union, because if you see on some products ‘Made in India’, ‘Made in China’, [it is] “urgh”. ‘Made in UK’, in Germany or Switzerland,” she said.

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.

EVPU declined to comment.

A spokesman for SGS said 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 OBL manufacture 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”.

A spokesman for ITC said: “As an EU notified body we comply in full accordance with the law.”

Turkish admission: approval of medical devices is a ‘money-making business’

An executive at a Turkish regulatory body has admitted that the process for approving medical devices is a “money-making business”.

Teoman Alpay, an executive at Kalitest, suggested that some regulatory bodies loosen the “requirements” for licensing an artificial hip by implementing a less rigorous approach towards European requirements. Turkey, which is not a member of the European Union, has been allowed to approve medical devices for sale in the single market since 2009.

In a meeting with people purporting to be from a Chinese firm seeking approval for a metal-on-metal hip implant, Mr Alpay said: “This is a money-making business.”

He added: “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 [Medical Devices Directive].” Mr Alpay said that it was true that some notified bodies did not comply, but they were not based in Turkey.

At Alberk, a notified body in Turkey located above a car mechanics in Istanbul, an executive also indicated he was prepared to overlook “minor” problems when considering a product for a licence. Kadir Tarakci said: “Small points is nothing for us because everyone has [omissions]. Everybody, trust me, everybody.”

Both firms said the executives who made the comments have since left the companies.

The comments from the two Turkish firms appear to highlight a problem with the system where competing regulatory bodies in Europe aggressively market their services to potential clients.