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Medical devices
Parliament wants tougher medical devices control without extra burdens for SMEs
Est. 4minThe 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.
MEPs vote for stricter approval system for medical devices
Est. 4minThe 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.
Danes want chemicals out of medical devices
Est. 3minDanish 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.
MEPs divided ahead of vote on medical devices
Est. 6minSPECIAL 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
Est. 10minSPECIAL 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.
Patient groups: Safety first in new medical devices regulation
Est. 6minSPECIAL 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
Est. 6minSPECIAL 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
Est. 2minFrench 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
Est. 3minGerman 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
Est. 3minCriminal 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
Est. 4minThe 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
Est. 4minThe 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
Est. 4minFollowing 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.
EU launches debate over authorisation of medical devices
Est. 3minA 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.
New-look association to shape medical technology future
Est. 2minIndustry 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.
Commission to sound out medical devices market
Est. 2minWith 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.
Interview: Medical device industry calls for more government support
Est. 3minMedical 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.
Concerns raised over use of chemicals in medical devices
Est. 2minExposure 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.
New institute to assess value of medical technology
Est. 2minA 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.
Commission consults public on medical devices
Est. 1minThe Commission is proposing amendments to regulations in the medical devices sector and is inviting the public to comment on its draft proposal.
Review of medical devices legislation in the making
Est. 2minDays before the publication of the first draft
of the reviewed medical devices directive, a Commission expert
set out the state of play to industry
representatives.
Medical devices reform may introduce precautionary principle
Est. 1minThe review of the EU's medical devices directives could see the
introduction of the 'precautionary principle' and stricter rules on
the re-use of medical devices which are intended for a single use
only.
Medical Devices: EU takes over chairmanship of global harmonisation task force
Est. 1minThe EU has chosen 'Enhancing Patient Safety' as the key theme for its three-year chairmanship of the Global Harmonisation Task Force on Medical Devices.
Commission to propose new legislation on human tissue products
Est. 1minA Commission report has mapped out the present state and future prospects for human tissue engineering in the EU, calling for an EU-wide regulatory framework in this field.