For years, concerns have been raised about Europe’s system for approving hip replacements, artificial knees and other products which have undermined the health of thousands of Britons.
In America, a government agency, the Food and Drug Administration (FDA), assesses whether companies should be able to market a device.
In the European Union, the task of determining whether a device is safe is effectively sub-contracted to a series of private firms called notified bodies.
Companies can approach any notified body, so a German company could get approval from a Hungarian company. More than 70 notified bodies compete for business.
The companies charge anything from €1,500 (£1,200) to €50,000 (£40,750)) for the coveted CE marking which licenses a product for sale across Europe.
There are two steps to gaining EU approval.
The first is to submit a “technical dossier,” which sets out the purpose of the device and the manufacturing process. The second step is a factory visit, so that auditors can see how the device will be produced.
After the initial approval is granted, the factories get an annual visit. The factories are forewarned about the inspection.
The limitations of the factory visits as a check on the system were laid bare last year in the Poly Implant Prothese (PIP) scandal, when an international maker of breast implants was shut down.
During a factory visit, it emerged that instead of using medical-grade silicon to produce the implants, the producers were using non-medical grade silicone intended for use in mattresses.
The French regulator finally issued a recall in 2010, nine years after the company started using the wrong material.
About 47,000 British women are believed to have been given faulty implants manufactured by the French company and the NHS is facing a multi-million pound bill as thousands of women come forward to have them removed.
If a company’s application fails, they are not supposed to submit the application to another notified body. However, there is no central record of the applications, so there is no way of establishing whether companies re-submit applications.
Experts have repeatedly raised concerns about the level of detail required by the notified bodies. The bodies can build up relationships with companies, meaning that one firm can represent a large tranche of an approval group’s business.
The notified bodies do not have to carry out their own tests on medical implants. Instead, companies can submit “a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device”.
Whereas a new drug must go through extensive clinical testing, a medical device can be approved on the basis of a file comparing it with other devices on the market.
In The Daily Telegraph’s dossier to a Slovakian notified body, the equivalent devices section was based on a withdrawn hip device which has been at the centre of an international scandal.