The European Commission and pan-European industry association Eucomed have responded to an investigative piece published by the Telegraph that exposed a pair of Notified Bodies who were apparently ready to help a company bring to market a hip implant modelled after a metal-on-metal device banned in the United Kingdom.
The European Commission told the Telegraph that it "recognises that there are some weaknesses in the current regulatory framework, and of course anything which jeopardises patients’ health or safety is unacceptable.” The Commission also noted that the new medical device regulations currently in Parliament include several measures that tighten regulatory oversight on high-risk devices, including hip implants, and subject Notified Bodies to increased oversight. The regulations are not expected to become law until mid-2014 at the earliest.
Noting that it is aware of the investigative report by the Telegraph conducted in association with the British Medical Journal, Eucomed issued the following statement:
"This illustrates Eucomed’s belief that Member States should accelerate the already identified improvements of Notified Bodies foreseen in the Immediate Action Plan of former Commissioner Dalli. In addition, Eucomed fully supports the measures concerning Notified Bodies in the European Commission proposal for a revision of the medical devices regulatory framework."
In the sting, reporters acting as representatives of a fake Chinese company wanting to introduce a metal-on-metal hip implant in the European market submitted a formal application to Notified Bodies in Slovakia and the Czech Republic. The Slovakian organisation was prepared to offer provisional approval for the design, while the body in the Czech Republic was considering licensing the product, reported the newspaper. The hip implant was designed with specifications similar to the Depuy ASR XL Acetabular System, which was recalled in 2010. Read more about this in "Faulty Medical Devices Back in News."