Tuesday

17th Oct 2017

Focus

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.

Thank you for reading EUobserver!

Subscribe now for a 30 day free trial.

  1. €150 per year
  2. or €15 per month
  3. Cancel anytime

EUobserver is an independent, not-for-profit news organization that publishes daily news reports, analysis, and investigations from Brussels and the EU member states. We are an indispensable news source for anyone who wants to know what is going on in the EU.

We are mainly funded by advertising and subscription revenues. As advertising revenues are falling fast, we depend on subscription revenues to support our journalism.

For group, corporate or student subscriptions, please contact us. See also our full Terms of Use.

If you already have an account click here to login.

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.

Analysis

Obesity linked to agricultural policy, new studies say

The number of obese children and adolescents worldwide has risen tenfold in the past four decades, according to the WHO. Health campaigners are pushing for a radical rethink of the EU's common agricultural policy to help tackle the obesity epidemic.

Analysis

Endocrine legislation could be delayed years after veto

MEPs last week blocked the European Commission's proposal to define hormone-disrupting chemicals, saying it did not go far enough to protect human health. They may inadvertently have kicked EU legislation on the matter into the next parliamentary term.

Stakeholder

Silicones - enabling the next big leap in prosthetics and health

Prosthetics have been used for hundreds of years, but for much of that time saw little technological development. Today, it is possible to replace lost limbs with high-tech prosthetics made with silicone, that function seamlessly and provide a natural appearance.

Supported by

Stakeholders' Highlights

  1. International Partnership for Human RightsEU Should Seek Concrete Commitments From Azerbaijan at Human Rights Dialogue
  2. European Jewish CongressEJC Calls for New Austrian Government to Exclude Extremist Freedom Party
  3. CES - Silicones EuropeIn Healthcare, Silicones Are the Frontrunner. And That's a Good Thing!
  4. EU2017EEEuropean Space Week 2017 in Tallinn from November 3-9. Register Now!
  5. European Entrepreneurs CEA-PMEMobiliseSME Exchange Programme Open Doors for 400 Companies Across Europe
  6. CECEE-Privacy Regulation – Hands off M2M Communication!
  7. ILGA-EuropeHealth4LGBTI: Reducing Health Inequalities Experienced by LGBTI People
  8. EU2017EEEHealth: A Tool for More Equal Health
  9. Mission of China to the EUChina-EU Tourism a Key Driver for Job Creation and Enhanced Competitiveness
  10. CECENon-Harmonised Homologation of Mobile Machinery Costs € 90 Million per Year
  11. ILGA-EuropeMass Detention of Azeri LGBTI People - the LGBTI Community Urgently Needs Your Support
  12. European Free AllianceCatalans Have Won the Right to Have an Independent State

Latest News

  1. Malta shocked after car bomb kills crusading journalist
  2. Spanish and Catalan leaders continue stand-off
  3. May pleads for more as EU makes Brexit gesture
  4. EU united in backing Iran deal, after Trump criticisms
  5. 'Think of the patients!' cry warring EMA-host cities
  6. In Iceland: Europe woos Arctic allies
  7. Austrian voters reject liberal pro-EU status quo
  8. Turkey urges EU not to break off ties