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Articles related to "Medical Devices: A new regulatory landscape"
News
MEPs divided ahead of vote on medical devices
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05 July 2013
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.
Medical tech sector worried about innovation, SMEs
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04 July 2013
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.
US doctors look with envy at Europe’s medical devices approval scheme
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03 July 2013
SPECIAL REPORT / The scrutiny procedure on medical devices in the US is so strict that American doctors say the system works against the interest of patients, leaving some waiting years for treatment that could save their lives. European doctors now start to worry that a similar system envisaged in the EU could have the same impact.
Patient groups: Safety first in new medical devices regulation
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02 July 2013
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.
EU at crossroads on new medical devices legislation
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01 July 2013
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.
650 French patients fitted with unauthorised replacement hips
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03 May 2013
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.
Parliament rapporteur proposes 'US system' for medical devices legislation
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22 April 2013
German centre-left MEP Dagmar Roth-Behrendt is proposing a centralised authority to approve medical devices before they are sold on the EU market.
Victims of breast implants seek compensation in France
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17 April 2013
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.
EU hesitates to follow US approach on medical devices
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20 March 2013
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.
Parliament wants tougher legislation on medical devices
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28 February 2013
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.
EU and medical devices industry at odds over regulation
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14 February 2013
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.
Opinion
More work needed to ensure safe medical devices in Europe
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01 July 2013
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.
