Sunday

17th Dec 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.

Council of Europe warns on backlash to abortion access

In recent years, proposals for bans and restrictions on voluntary terminations have risen in some EU member states - as well as bills proposing more 'conditions' before women are allowed to access abortions.

EU calls for better disease prevention

EU health commissioner Vytenis Andriukaitis is encouraging states to spend more to prevent diseases that weigh much on health systems.

Supported by

News in Brief

  1. EU adopts 'track-and-trace' tobacco system
  2. Luxembourg appeals Amazon tax decision
  3. EU leaders agree to open phase 2 of Brexit talks
  4. Juncker: May made 'big efforts' on Brexit
  5. Merkel took 'tough' line on Russia at EU summit
  6. EU leaders added line supporting 'two-state' solution
  7. EU leaders agree to 20 European Universities by 2024
  8. Belgian courts end legal proceedings against Puigdemont

Stakeholders' Highlights

  1. Dialogue PlatformThe Gülen Community: Who to Believe - Politicians or Actions?" by Thomas Michel
  2. Plastics Recyclers Europe65% plastics recycling rate attainable by 2025 new study shows
  3. European Heart NetworkCommissioner Andriukaitis' Address to EHN on the Occasion of Its 25th Anniversary
  4. ACCACFOs Risk Losing Relevance If They Do Not Embrace Technology
  5. UNICEFMake the Digital World Safer for Children & Increase Access for the Most Disadvantaged
  6. European Jewish CongressWelcomes Recognition of Jerusalem as the Capital of Israel and Calls on EU States to Follow Suit
  7. Mission of China to the EUChina and EU Boost Innovation Cooperation Under Horizon 2020
  8. European Gaming & Betting AssociationJuncker’s "Political" Commission Leaves Gambling Reforms to the Court
  9. AJC Transatlantic InstituteAJC Applauds U.S. Recognition of Jerusalem as Israel’s Capital City
  10. EU2017EEEU Telecom Ministers Reached an Agreement on the 5G Roadmap
  11. European Friends of ArmeniaEU-Armenia Relations in the CEPA Era: What's Next?
  12. Mission of China to the EU16+1 Cooperation Injects New Vigour Into China-EU Ties

Latest News

  1. Catalonia, Brexit, and Uber on EU agenda This WEEK
  2. Macron and Merkel take tough line on Poland
  3. Eurozone future needs structural reforms, EU leaders told
  4. Showdown EU vote on asylum looking likely for next June
  5. EU stresses unity as it launches next phase of Brexit talks
  6. Polish PM ready for EU sanctions scrap
  7. Dutchman to lead powerful euro working group
  8. EU mulls post-Brexit balance of euro and non-eurozone states

Stakeholders' Highlights

  1. EPSUEU Blacklist of Tax Havens Is a Sham
  2. EU2017EERole of Culture in Building Cohesive Societies in Europe
  3. ILGA EuropeCongratulations to Austria - Court Overturns Barriers to Equal Marriage
  4. Centre Maurits CoppietersCelebrating Diversity, Citizenship and the European Project With Fundació Josep Irla
  5. European Healthy Lifestyle AllianceUnderstanding the Social Consequences of Obesity
  6. Union for the MediterraneanMediterranean Countries Commit to Strengthening Women's Role in Region
  7. Bio-Based IndustriesRegistration for BBI JU Stakeholder Forum about to close. Last chance to register!
  8. European Heart NetworkThe Time Is Ripe for Simplified Front-Of-Pack Nutrition Labelling
  9. Counter BalanceNew EU External Investment Plan Risks Sidelining Development Objectives
  10. EU2017EEEAS Calls for Eastern Partnership Countries to Enter EU Market Through Estonia
  11. Dialogue PlatformThe Turkey I No Longer Know
  12. World Vision7 Million Children at Risk in the DRC: Donor Meeting to Focus on Saving More Lives