Sunday, November 11, 2012

Notified bodies: are they fit for purpose?

Medical Device Regulation


BMJ2012;345doi: 24 October 2012)
Cite this as:BMJ2012;345:e7177
Deborah Cohen explains how medical devices get on to the European market
Slick and efficient or opaque and patchy—these are two of the views about the European medical device regulatory system expressed during a US Congress debate last year.1 Over the past few years there has been mounting concern about Europe’s system for approving high risk medical devices such as hip replacements, cardiac pacemakers, and other implants.

In the United States, the Food and Drug Administration (FDA) assesses whether companies should be able to market a device. However, in the European Union the task of determining whether a medical device is safe and performs according to certain standards is effectively subcontracted to private firms called notified bodies.

Companies can approach any notified body, so a German company could get approval from a Hungarian company. Over 70 notified bodies compete for business.

The companies charge anything from €2750 (£2240; $3590) to €50 000 for the coveted CE certificate that enables a company to affix a CE mark on its product and sell it across Europe.

There are two steps to gaining this certificate. The first is to submit a “technical dossier,” which sets out the purpose and the design 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 visit.

The limitations of the factory visits as a check on the system were laid bare last year in the Poly Implant Prothèse (PIP) scandal, when the international maker of breast implants was shut down. During a factory visit, it emerged that instead of using medical grade silicone to produce the implants, the manufacturer was using 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. Around 47 000 British women are believed to have been given faulty implants manufactured by the French company, and the NHS is facing a multimillion pound bill as thousands of women come forward to have the implants removed.

If a company’s application fails, it is not supposed to submit the application to another notified body. However, as there is no central record of the applications, there is no way to establish whether companies resubmit applications.

Experts have repeatedly raised concerns about the level of detail required by the notified bodies. Notified bodies can build up relationships with companies, meaning that one company can represent a large tranche of a notified body’s business.

Nor do medical implants have to be tested in clinical studies. 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 BMJ and Daily Telegraph’s dossier to a Slovakian notified body, the equivalent devices section was based on two recalled hip implants—one of which has been at the centre of an international scandal—and two that are subject to legal action.

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