Medical devices face tougher premarket testing under new EU laws

BMJ 2017; 357 doi: (Published 13 April 2017) Cite this as: BMJ 2017;357:j1870
  1. Deborah Cohen
  1. The BMJ

The European Parliament has passed new legislation to tighten regulation of medical devices that will require high risk devices, such as hip implants, to undergo more premarket testing and assessment.

European device regulation has come in for criticism after a series of high profile failures—including hip replacements, breast implants, and pelvic meshes—that have resulted in harm to patients.

MEPs voted in a raft of changes detailed in a 600 page dossier that has taken over five years to agree. At the heart of the updated legislation is the need for more clinical evaluation before and after a device is put on the market. Manufacturers of high risk devices will have to perform clinical investigations, and the results of these will have to be published on an accessible database.

If a company is to argue that its product is like another already being sold and does not need clinical evaluation—so called “similar equivalence”—it will have to require the necessary documentation from the company producing it to prove it.

Despite arguments for moving to a single European regulatory body for devices, akin to the European Medicines Agency for drugs or the US Food and Drug Administration, the series of EU-wide private organisations called notified bodies will remain. These will retain responsibility for assessing devices before they go on the market, but the new legislation will require that they have the necessary expertise to evaluate the information supplied by manufacturers.

The number of notified bodies has fallen from 80 to 56 in recent years, as it became apparent that many of them lacked the ability to assess devices, and member states will have more oversight of their performance.

To aid the notified bodies the European Commission will set up expert panels to advise on whether a high risk device should be approved. This will be non-binding advice, but the panels’ decisions will be published.

Ilaria Passarani, head of the Food and Health Department of the European Consumer Organisation, an umbrella group for national consumer organisations across Europe that campaigned for more robust premarket authorisation, broadly welcomed the new laws. But she cautioned that they would not properly come into effect for another five years.

Passarani said that some “major positive changes” were being introduced, including “stronger” postmarket surveillance, better information for consumers, stricter rules on clinical investigations, and more transparency of data. “If properly implemented, the new rules will help prevent faulty devices from ending up in patients’ bodies and disrupting their lives,” she said.

Alan Fraser, emeritus professor of cardiology at Cardiff University and an expert member of the European Commission’s Clinical Investigation and Evaluation Working Group (for medical devices), agreed that transparency was key. “All healthcare professionals should choose the devices that they recommend for their patients after evaluating the evidence from clinical studies,” he said. “The new regulation requires that a summary of clinical evidence will be prepared by the manufacturer, but there should be full access to the clinical data concerning new medical devices.”

However, Glenis Wilmott MEP, the European Parliament’s lead negotiator on medical devices regulation and Labour’s European spokeswoman on health, cautioned about the effect of Brexit. She said, “It would be unacceptable if Brexit meant that patients in the UK got less protection than those in the rest of the EU or waited longer for access to new medical devices. The government must maintain these new laws after the UK leaves the European Union.

“Not only would patient safety be at risk, but the medical devices industry—an important sector in the UK—and manufacturers based in Britain will still have to comply with these requirements in order to market their products in the EU, so it would make no sense for the government to repeal these laws and require them to apply for authorisation twice.

“There is also no guarantee that the UK will still have access to the EU-wide database for sharing information on medical devices after Brexit. The government must ensure continued close cooperation with the EU on monitoring medical device safety.”

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