Feature Medical Device Regulation

Manufacturers offered helping hand with EU approval

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7225 (Published 25 October 2012) Cite this as: BMJ 2012;345:e7225
  1. Deborah Cohen, investigations editor
  1. 1BMJ, London WC1H 9JR, UK
  1. dcohen{at}bmj.com

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 …

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