Definitely worth paying attention to – as written by Sarah Boseley in yesterday’s Guardian.
“Many people would suppose that medical devices are subject to the same stringent approval and inspection processes as medicines. But they would be wrong.
When it comes to devices such as hip joints and breast implants, a manufacturer is not required to win a licence based on evidence of safety and efficacy from clinical trials. Instead, they must get a CE mark which certifies the product reaches a certain European quality standard. It is the same mark that a Chinese toy company, for example, would have to obtain to sell yo-yos in Europe.
Medical devices are an enormous global industry, with 18,000 companies in Europe alone. As production has become cheaper elsewhere, so companies have moved…”
Full article available here.
