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22nd Aug 2017

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Breast implant scandal triggers more EU oversight

  • Medical device is a broad category, which made agreeing on new rules difficult, says MEP Peter Liese (Photo: European Parliament)

A broad range of medical devices - from stethoscopes to breast implants - will be put under greater scrutiny in the EU after the European Parliament agreed on new rules on Wednesday (5 April).

The new legislation will require the private organisations that certify medical devices, to do spot checks, including after the device has been certified.

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This is the EU's response to a scandal involving breast implants, which saw French company Poly Implant Prothese (PIP) cheating with regard to the components of the implants.

Following the scandal, the European Commission proposed new rules in 2012, which needed to be adopted by the parliament, and by the Council of the EU, where the governments of member states meet.

“Citizens are asking me quite rightly why it takes so long,” said centre-right MEP Peter Liese, who was involved in compromise negotiations with member states.

“I think part of the answer is that it's very complex, we're talking about all sorts of products,” he told EUobserver on Wednesday ahead of the vote.

“But I think that we also need to see that the parliament reacted in the autumn of 2013, one year after the commission proposal was made. It took 2.5 years for the council to decide on its position,” noted Liese.

The new rules will apply to medical devices.

“Anything that you have not injected or swallowed can be categorised as medical device”, said Liese.

Member states determine whether something is categorised as a medical device, but it is private companies - known legally as notified bodies - that are in charge of certification.

The system came under scrutiny when it emerged that PIP had used a cheaper type of silicon in its breast implants, instead of medical-grade silicon.

Post-approval checks

Two months ago, the Court of Justice of the EU ruled that the notified body which had approved the PIP breast implants, TUV Rheinland, was not required by EU law to proactively carry out post-approval checks.

“In the future they will be obliged” to do so, said Liese.

The German MEP noted that during the legislative process there was “some discussion” about whether state authorities should take over the approval process, but this option was discarded.

“Unannounced controls are much more important than any kind of improvement which we could do in the approval system,” he said.

“It is not a guarantee that you don't have scandal when you have a state authority,” said Liese, noting that in the Dieselgate emissions scandal it was state authorities “that failed”.

The MEP agreed that there is some “similarity” between the medical devices file and Dieselgate.

“There was a legislation obviously not fit for purpose and it took a big scandal to draw consequences,” he said.

Another improvement, Liese added, was that experts from national governments will go and check the work of the notified bodies.

The new rules are laid down in two regulations, one on general medical devices, and one on in vitro diagnostic medical devices. The latter refers to test devices, such as technologies that carry out genetic tests.

Both were adopted by the European Parliament with an overwhelming majority.

Ukip opposition

In terms of the procedure, a vote had not been necessary. But the British eurosceptic party, Ukip, had filed amendments and called for the rejection of the two legislative proposals.

The amendment to reject the medical devices text received support from 66 MEPs, and was rejected by 635, with two MEPs abstaining.

The amendment to reject the in vitro diagnostic medical devices regulation received support from 59 MEPs, and was also rejected by 635. Nine MEPs abstained.

Ukip has 20 MEPs, and the other votes are likely to have come from other eurosceptic MEPs.

During the plenary session, Liese said he was “almost grateful” that the UK Independence Party (Ukip) had called for a vote, since it gave MEPs the opportunity on the same day as a resolution on Brexit was adopted “to show unity against Ukip's ideas”.

“We are deciding something for the internal market which will help patients throughout Europe,” he said.

Wednesday's vote was the last step in the legislative process. The proposals will now become law.

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