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More work needed to ensure safe medical devices in Europe
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.
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Medical Devices: A new regulatory landscape
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.
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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.
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US doctors look with envy at Europe’s medical devices approval scheme
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
