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.
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.
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.
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.
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.
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.
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.
Small firms in the health sector are waiting up to 700 days to be paid by public bodies, John Wilkinson, chief executive of Eucomed, the European Medical Technology Industry Association, told EURACTIV in an interview.
Health care systems should reimburse medical devices to support innovation in this booming sector, which, according to the European medical technology industry association (Eucomed), is going to help eHealth and bring solutions faster than the pharmaceutical industry.
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.
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.
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.
The 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