Medical devices

Health 03-05-2017

Brexit regulatory uncertainty ‘threatens UK med tech’

Regulatory uncertainty in the wake of Brexit could leave Britain's multi-billion-pound medical technology industry out in the cold, with separate regulatory systems threatening exports and jobs.

Health 06-04-2017

Parliament wants medical devices traced, scrutinised

After almost five years of talks with member states, on Wednesday (5 April), the European Parliament adopted two new regulations imposing stricter rules on medical devices’ safety.

Health 23-01-2017

Breast implant victims win payout from German safety body

A French court on Friday ordered German safety certifier TUV to pay €60 million in compensation to 20,000 women who received defective breast implants that the group had approved.

Health 21-10-2016

Andriukaitis: Health Technology Assessment will make EU healthcare ‘sustainable’

EXCLUSIVE / National healthcare systems should embrace the digital era and use Health Technology Assessment (HTA) to become truly sustainable and cost-effective, European Commissioner for Health and Food Safety Vytenis Andriukaitis told in an interview.

Health 13-06-2016

New medical devices rules should avoid ‘unnecessary’ red tape, industry says

The implementation of new rules on medical devices should avoid extra burdens and unnecessary bureaucracy, health industry officials have told

Health 23-10-2013

Parliament wants tougher medical devices control without extra burdens for SMEs

The European Parliament on Tuesday (22 October) voted to improve the control on medical devices via strengthened traceability rules and transparency of information for patients and medical staff, but without creating additional burdens for small manufacturers.

Health 26-09-2013

MEPs vote for stricter approval system for medical devices

The European Parliament's committee for the environment and public health (Envi) on Wednesday (25 September) voted for stricter rules on medical devices, including a new pre-market approval system, more transparency and better traceability.

Health 09-07-2013

Danes want chemicals out of medical devices

Danish Health Minister Astrid Krag wants phthalate chemicals, which are used to soften plastic, phased out as part of the EU's new medical devices regulation.

Health 05-07-2013

MEPs divided ahead of vote on medical devices

SPECIAL REPORT / A vote in the European Parliament's Environment, Public Health and Food Safety (ENVI) Committee over the EU's proposed new medical devices regulation, which was supposed to take place on 10 July, has been postponed until September to give lawmakers more time to work on compromise amendments.

Health 04-07-2013

Medical tech sector worried about innovation, SMEs

SPECIAL REPORT / The European medical technology industry worries that a centralised pre-market authorisation system in Europe will destroy innovation, research and development within the sector. It warns especially that small and medium-sized enterprises (SMEs) could disappear with the proposed new system.

Health 02-07-2013

Patient groups: Safety first in new medical devices regulation

SPECIAL REPORT / Recent health scandals involving faulty breast implants and toxic replacement hips have illustrated the need to strengthen safety checks on medical devices in the EU, according to patient groups. A new EU regulation currently in the works must rectify this by putting patient safety first, they argue.

Health 01-07-2013

EU at crossroads on new medical devices legislation

SPECIAL REPORT / While the EU institutions, industry, health campaigners and doctors all agree that the European approval system for medical devices – ranging from contact lenses to pacemakers – needs to be updated, the way forward on how to do it leaves politicians and stakeholders divided.

Health 03-05-2013

650 French patients fitted with unauthorised replacement hips

French surgeons have fitted 650 people with replacement hips that had not yet been certified as meeting European standards, health officials said on Thursday (2 May). The case resembles last year's scandal over faulty breast implants, which triggered a revision of the EU's legislation on medical devices.

Health 22-04-2013

Parliament rapporteur proposes ‘US system’ for medical devices legislation

German centre-left MEP Dagmar Roth-Behrendt is proposing a centralised authority to approve medical devices before they are sold on the EU market.

Health 17-04-2013

Victims of breast implants seek compensation in France

Criminal fraud proceedings began today (17 April) in France over a breast implants scandal that affected 400,000 women globally. The case highlights the continuing absence of a European collective judicial redress tool for victims, says a European consumer organisation.

Health 20-03-2013

EU hesitates to follow US approach on medical devices

The European Parliament and the Commission are at odds over proposals to create a US-inspired centralised approval system for medical devices, which supporters say would improve patient safety.

Health 28-02-2013

Parliament wants tougher legislation on medical devices

The European Commission has proposed a new regulation on medical devices in Europe, following the 2012 health scandal involving breast implants. But the new proposals do not go far enough, says the Parliament's rapporteur on the issue.

Health 14-02-2013

EU and medical devices industry at odds over regulation

Following the implant scandal in which women were given industrial rather than medical-grade silicon, the EU has moved to tighten up regulation on medical devices. But industry says the new proposal “does not contribute to patient safety” and will affect the EU’s speed to market and cripple innovation.

Health 26-09-2012

EU launches debate over authorisation of medical devices

A draft update to the Medical Devices Directive, to be published today (26 September), is set to spark a debate over authorisation, with the European Parliament likely to call for stronger measures in the wake of the PIP silicon breast implant scandal in France.

Public Affairs 15-04-2010

New-look association to shape medical technology future

Industry association Eucomed, which represents European medical technology firms, yesterday (14 April) appointed a new board to ensure that its governance structure reflects the sector's evolution into a diverse and highly innovative industry.  

Health 09-05-2008

Commission to sound out medical devices market

With a plethora of directives currently regulating the market for medical devices such as syringes and pacemakers, the Commission has launched a consultation to streamline legislation in this area.

Health 15-02-2008

Interview: Medical device industry calls for more government support

Medical devices ranging from simple needles to life-saving high-tech implants should receive stronger support from governments as they help patients faster than drugs do, argues the European medical technology industry association (Eucomed) in an interview with EURACTIV.

Health 17-10-2007

Concerns raised over use of chemicals in medical devices

Exposure to 'phthalates', a chemical component contained in some PVC-made medical devices, harms patients' health, an EU scientific committee concluded in a study. The findings come after a ban on phthalates in toys was decided upon in 2005.

Health 08-10-2007

New institute to assess value of medical technology

A new institute will aim to bridge the gap between medical technology, innovation and healthcare policy to provide policymakers with evidence of the social and economic value of medical technology, and medical devices in particular.