20th Aug 2019

Medical devices face uncertain diagnosis in EU

  • Internal wrangling has delayed the law (Photo: Helena Spongenberg)

Health scandals about hip replacements depositing toxic metals into the blood or breast implants made from unauthorised industrial-grade silicone have, in recent years, stunned European citizens.

The latter scandal caused a health scare across Europe and the rest of the world after 300,000 women in 65 countries were believed to have received the unauthorized breast implants, which had double the risk of ruptures. The main market was in Europe, notably in France.

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This happened four years ago.

As a direct response, the European Commission wanted to tighten legislation. “We must do our best never to let this happen again,” John Dalli, EU health commissioner at the time, said.

The commission’s proposal for a revision of the regulation came in 2012. It aimed to improve patient safety by making future medical devices, ranging from simple sticking plasters to life-supporting machines, subject to far more stringent tests before they enter the market.


Originally, the aim was to adopt the new legislation before the EU elections this year, but that didn't happen. The deadline was then postponed until the end of 2014.

On 1 December the council, representing member states, announced that it will not reach agreement this year.

Member states are divided on issues ranging from tasks for a proposed medical device coordination group, to the scrutiny mechanism for high-risk devices and post-market surveillance.

At the meeting, the commission reminded member states that they, just a few months ago, agreed that a quick adoption of these proposals was vital.

France was especially eager to get the new legislation through, partly because the breast implants scandal in 2010 revolved around a French company, Poly Implant Prothese (PIP).

Criticism from MEPs

Politicians in the European Parliament are also keen on seeing this legislation adopted.

Danish Green MEP Margrete Auken, member of the public health committee, said new scandals with dangerous medical devices could still occur because of the delay.

“As long as the Council is dragging its feet, we will not conclude our work on this important file. And the longer we wait before agreeing on ambitious checks of the implants, the longer we will continue to experience injuries among our citizens,” she told EUobserver.

The EU parliament endorsed the commission's proposal back in October 2013 .

German centre-right MEP Peter Liese, a member of the same committee, also sees a need to conclude the file as soon as possible.

“The parliament has been waiting for a council position for more than a year now. A further delay endangers not only patients' safety, but also the planning reliability of the companies working with medical devices,” he said.

Laws cannot prevent fraud

But even if the aim of the new legislation is to prevent future scandals, it may not prevent a repeat of the French scandal, according to Alan Fraser, chairman of the task force on medical devices for the European Society of Cardiology.

“Firstly, the French case was an instance of fraud, so any system might be liable to such problems if a manufacturer is unscrupulous,” he said.

”But it also occurred, in part, because the regulatory authority in France and the notified body in Germany did not conduct regular or unannounced checks of the manufacturing process,” he added.

He notes that it is member states' hands whether the legislation will adequately address the concerns about the current system. However it is inclear when governments will and when the law will come into force.

“My understanding is that new rules are unlikely to be fully enacted before 2020,” Fraser said.

According to Laurene Souchet, policy officer at the European Patients' Fourm, the consequences of a delay is “that patients in Europe cannot yet report directly incidents they encounter with medical devices, or receive more transparent information on devices, particularly the high risk devices”.

Although Souchet hopes to see progress in 2015, she also wants the EU institutions to get the regulation right the first time.

“Once adopted it will stay adopted for many years, and we have to make sure the compromise made will provide patients with access to safe, high quality medical devices in the EU," she said.

Maria Danmark is a Danish journalism student at the Utrecht University in the Netherlands.

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