EurActiv.com

EU news and policy debates across languages

25/09/2016

New-look association to shape medical technology future

Topic: medical devices


Health & Consumers 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 EurActiv.com.
VideoPromoted
Health & Consumers 21-04-2016

Hearing awareness: professional hearing care makes you smarter and healthier

Around 16% of adult Europeans experience hearing loss severe enough to have a negative impact on their daily lives.
Health & Consumers 01-12-2015

MedTech: Investing in medical technology can fix inefficiencies

Healthcare systems must pay for the medical technology bill - but they should do it smartly, so that therapies, used in the right way with the right patients, can help save costs, MedTech's chief executives believe.
Health & Consumers 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 & Consumers 22-10-2013

Parliament wants stricter control on medical devices

The European Parliament on Tuesday (22 October) voted to improve the control for medical devices via strengthened traceability rules and transparency of information for patients and medical staff, but without creating additional burden for small manufacturers.
Health & Consumers 18-10-2013

MEPs can make an informed decision on medical devices in Europe

On 22 October, the Parliament will vote to decide the course of the EU's Medical Devices Regulation, but several of the amendments proposed by the ENVI Committee could endanger patients, in particular one that allows for the re-use of all medical devices, says Serge Bernasconi.
Health & Consumers 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 & Consumers 23-09-2013

A few points that MEPs must consider ahead of medical devices vote

The European Parliament will vote soon on medical devices regulation, but a new set of amendments, which most MEPs have not had the time to assess, are being rushed through, says Serge Bernasconi.
Health & Consumers 12-09-2013

Medical devices rules: Patients' safety must be reinforced

The inadequacy of the EU's legislation on medical devices was highlighted by several recent serious safety problems. In order to regain citizens’ trust, the European Union must reinforce its legislative framework, write several associations.
Health & Consumers 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.
NewsSpecial Report
Health & Consumers 05-07-2013

MEPs divided ahead of vote on medical devices

SPECIAL REPORT / 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.
NewsSpecial Report
Health & Consumers 04-07-2013

Medical tech sector worried about innovation, SMEs

SPECIAL REPORT / 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.
NewsSpecial Report
Health & Consumers 02-07-2013

Patient groups: Safety first in new medical devices regulation

SPECIAL REPORT / 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.
OpinionSpecial Report
Health & Consumers 01-07-2013

More work needed to ensure safe medical devices in Europe

SPECIAL REPORT / As the EU regulation on medical devices is under review, much remains to be done to reassure European consumers about the safety of these products, argues Monique Goyens.
NewsSpecial Report
Health & Consumers 01-07-2013

EU at crossroads on new medical devices legislation

SPECIAL REPORT / 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.
NewsSpecial Report
Health & Consumers 03-05-2013

650 French patients fitted with unauthorised replacement hips

SPECIAL REPORT / 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.
NewsSpecial Report
Health & Consumers 22-04-2013

Parliament rapporteur proposes 'US system' for medical devices legislation

SPECIAL REPORT / 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 & Consumers 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.
NewsSpecial Report
Health & Consumers 20-03-2013

EU hesitates to follow US approach on medical devices

SPECIAL REPORT / 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 & Consumers 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.
NewsSpecial Report
Health & Consumers 14-02-2013

EU and medical devices industry at odds over regulation

SPECIAL REPORT / 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.
LinksDossierSpecial Report
Health & Consumers 13-11-2012

Medical Devices: A new regulatory landscape

SPECIAL REPORT / Following a huge health scandal involving faulty breast implants sold around Europe, the European Commission published proposals in late 2012 for a new regulatory regime for medical devices.
Health & Consumers 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.