Saturday

3rd Dec 2022

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.

Read and decide

Join EUobserver today

Become an expert on Europe

Get instant access to all articles — and 20 years of archives. 14-day free trial.

... or subscribe as a group

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.

Feature

Medical technology: Advancing too fast for its own good?

The rapid advancement of medical technology has contributed to people living longer, healthier lives but consumer and campaign groups say devices should come under more scrutiny before they are used on patients.

Crowded race to win EU medicines agency

As cities line up to take over the European Medicines Agency some fear a kerfuffle that could destabilise the agency's work and slow down the pace of approving new medicines.

Opinion

On breast cancer our work is far from over

Breast cancer is still the most frequent cause of cancer death for women in Europe - but life expectancy of patients in Romania or Poland are lower than the EU average, and screening programmes vary hugely.

Investigation

EU lawmakers under pressure to act on 90,000 asbestos deaths

The EU Commission has watered-down a broad political initiative —but now governments of member states hold the key to what the EU should do. Some member states and regions have adopted asbestos strategies of some kind, from Poland to Flanders.

Investigation

Asbestos — two to three times more deadly than known

Where once working men in heavy industry were diagnosed with cancers related to a more direct exposure to asbestos, now women in professions such as teaching, nursing and other occupations are being diagnosed, as well as young people.

Opinion

How EU banks underwrote the Qatar World Cup

European banks and investors have invested heavily in Qatari sovereign bonds, and construction and hospitality companies — with scant attention to well-documented human rights violations.

Stakeholders' Highlights

  1. Nordic Council of MinistersCOP27: Food systems transformation for climate action
  2. Nordic Council of MinistersThe Nordic Region and the African Union urge the COP27 to talk about gender equality
  3. International Sustainable Finance CentreJoin CEE Sustainable Finance Summit, 15 – 19 May 2023, high-level event for finance & business
  4. Friedrich Naumann Foundation European DialogueGender x Geopolitics: Shaping an Inclusive Foreign Security Policy for Europe
  5. Obama FoundationThe Obama Foundation Opens Applications for its Leaders Program in Europe
  6. EFBWW – EFBH – FETBBA lot more needs to be done to better protect construction workers from asbestos

Latest News

  1. EU must break Orbán's veto on a tax rate for multinationals
  2. Belarus dictator's family loves EU luxuries, flight data shows
  3. How Berlin and Paris sold-out the EU corporate due diligence law
  4. Turkey's EU-funded detention centres ripe with abuse: NGO
  5. In green subsidy race, EU should not imitate US
  6. EU Commission proposes suspending billions to Hungary
  7. EU: Russian assets to be returned in case of peace treaty
  8. Frontex leadership candidates grilled by MEPs

Stakeholders' Highlights

  1. European Committee of the RegionsRe-Watch EURegions Week 2022
  2. UNESDA - Soft Drinks EuropeCall for EU action – SMEs in the beverage industry call for fairer access to recycled material
  3. Nordic Council of MinistersNordic prime ministers: “We will deepen co-operation on defence”
  4. EFBWW – EFBH – FETBBConstruction workers can check wages and working conditions in 36 countries
  5. Nordic Council of MinistersNordic and Canadian ministers join forces to combat harmful content online
  6. European Centre for Press and Media FreedomEuropean Anti-SLAPP Conference 2022

Join EUobserver

Support quality EU news

Join us