Feature Medical Device Regulation

The truth behind “made in Europe” labels on medical devices

BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e7193 (Published 24 October 2012) Cite this as: BMJ 2012;345:e7193
  1. Deborah Cohen, investigations editor
  1. 1BMJ, London WC1H 9JR, UK
  1. dcohen{at}bmj.com

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. …

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