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.
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.
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.
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.
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.
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.
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.
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.
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.