News
Telegraph reports on undercover investigation
An undercover instigation by the Telegraph (UK newspaper) along with the British Medical Journal claims to have uncovered serious loopholes in the EU medical device approval system. A group of experts created a document which described a fictitious hip replacement based on a similar banned product that is said to have caused problems in thousands of patients. This document was then submitted to notified bodies in Slovakia for approval, which was then provisionally granted. Later in the Czech Republic it was also provisionally granted approval, with one representative of a notified body stating that they were on the side of the manufacturer not the patients. The notified body also altered the fee depending on whether or not they passed the application. Compared with the approval system for drugs the medical device system was described as “woeful”. Full article available from here.
Last modified: Fri, 22 Feb 2013 12:12:25 GMT