A question of invasive supervision

EU policymakers are debating how closely they should police the national bodies that approve medical devices

One area of regulating healthcare in which the European Union has been making progress is invasive medical devices. The EU’s system of 80 independent ‘notified bodies’, which approve devices such as implants and pacemakers, is credited with bringing products to market three years faster than in the United States, which uses a single, centralised approval process.

But last year’s Poly Implant Prothèse (PIP) breast-implant scandal in France raised serious questions about the EU’s system. PIP is alleged to have used an industrial-grade silicone instead of medical silicone in the implants, making them prone to rupture. The implants were approved by a private German notified body.

Even if there had been no PIP scandal, the European Commission was due last year to propose a revision of the 1990 rules for approval of medical devices.

In response to the implant scare, there were calls to scrap the EU’s system of independent approval bodies in favour of a centralised EU system. But the Commission’s proposed revision of the rules, unveiled in September, stopped short of such a drastic revision. Instead, it proposes setting up an EU-level supervisory group to oversee the work of the notified bodies. It would also create an extended EU-wide database on medical devices so they can be tracked.

Last year, John Dalli, then the European commissioner for health and consumer policy, stressed that a centralised system would not have prevented the PIP case. “PIP was using products under specifications that were totally different from what was authorised,” he said. The new requirements for more thorough checking after an authorisation would rectify this problem.

Tough negoatiations

The initial proposal was cautiously welcomed by health campaigners and the medical devices industry. But the real battle is now unfolding as the legislation works its way through the European Parliament and European Council.

Campaigners and some MEPs are calling for an EU supervisory group to be given the ability to block pre-market approval of the most invasive products and to ask for more information about them.

Sascha Marschang, of the European Public Health Alliance, said the supervisory group had to be given real powers as part of the approval process. “Some of the notified bodies are operating more like free-market players, which would invite shopping around Europe for notified bodies to approve a medical device,” he said. “That’s not acceptable. There needs to be something slightly stricter.” EU consumers group BEUC is also calling for greater pre-market controls at EU level.

But Serge Bernasconi, of industry association Eucomed, said that this kind of intense scrutiny would delay getting life-saving devices to patients. “The scrutiny procedure would be the second approval of a device,” he said. “At the time they raise a question, the clock is stopped. If it’s a simple question, you can get the answer in a couple of weeks. But if the [supervisory group] says…why don’t you redo your efficacy studies, that could take a couple of years.”

Bernasconi adds that, because medical devices are harder to protect with patents than pharmaceuticals, such a delay could mean the product will be copied while approval is pending. Instead, companies should be asked to carry out post-marketing studies, he says, with a commitment from the industry to provide information on how the products are performing in real-life situations.

Eucomed says that instead of strengthening the centralised supervisory group, the notified bodies should be strengthened and made more specialised.

The Commission says that centralised pre-marketing authorisation by the supervisory group runs contrary to the intent of the reform, which is to make sure that all the notified bodies are operating with the same level of quality and scrutiny. “You do not increase the safety if you do a pre-marketing authorisation,” said Paola Testori Coggi, director-general of health and consumer policy in the Commission. “You increase the safety if you do more monitoring and surveillance of the devices.” Even with a pre-marketing authorisation, the breast implant scandal would still have happened, she said.

As the proposal works its way through the legislative process, the Commission has already started preparing for the changes it envisages. Last week (5 April), it adopted standards for the ‘unique device identification’ numbers that will keep track of the devices in the new database. The Food and Veterinary Office, the EU inspection agency that would visit notified bodies, has already carried out ‘test’ inspections at bodies in Germany, Denmark and the UK.

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