An investigation carried out by British journalists shows weakness on European Notified Bodies regulation. The Commission’s proposal for the revision of the medical device directive (released last 26 September) underlines the urgency for a stricter regulatory framework for medical devices.
Over the past ten months, the UK journals, The Daily Telegraph and the British Medical Journal (BMJ) headed an investigation to test Europe’s systems of regulation of high-risk medical devices. The two jpurnals set up a fictitious company to try to get approval, from notified bodies, for a metal-on-metal hip prosthesis – a device modelled on an implant that has been described as one of the biggest disasters in orthopaedic history.
The undercover investigation produced hard-core evidence showing that the current legislation is not enough to guarantee patient safety.
The investigative journalists, who “only went to notified bodies that were able to certify high risk devices”, visited 14 notified bodies to get approval for the flawed product. The reporters found that only four of them raised concerns about the implant, and three were happy to give them approval straight away.
Another conclusion on this investigation is related to the varying standards they found among notified bodies – a fact confirmed by a notified body in Turkey.
Some notified bodies requested “extra money” to speed the process up and to provide consultancy. The official procedure of approving medical devices is a money-making business as stated by one notified body stating “All organisations have to earn money. Either it’s a non-profit or profit business (…). Notified bodies work on the basis of making money to pay salaries and operating costs.”
The investigation reveals that this device, classified as one of the most invasive devices, can go into the market without rigorous pre-market assessment. For some notified bodies literature review of the evidence from a similar prosthesis can be enough.
The investigation has already received the attention of England’s Health Secretary, Jeremy Hunt, who stressed that this situation is “unacceptable” and that “the safety of patients is paramount (…)”.
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