Medical devices Archives

A French court on Friday ordered German safety certifier TUV to pay €60 million in compensation to 20,000 women who received defective breast implants that the group had approved.

The Maltese EU presidency will seek more transparency in the way pharmaceutical companies negotiate with member states on medicines’ pricing, Health Minister Chris Fearne said in an interview with EURACTIV.

EXCLUSIVE / National healthcare systems should embrace the digital era and use Health Technology Assessment (HTA) to become truly sustainable and cost-effective, European Commissioner for Health and Food Safety Vytenis Andriukaitis told EURACTIV.com in an interview.

The implementation of new rules on medical devices should avoid extra burdens and unnecessary bureaucracy, health industry officials have told EURACTIV.com.

Healthcare systems must pay for the medical technology bill - but they should do it smartly, so that therapies, used in the right way with the right patients, can help save costs, MedTech's chief executives believe.

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 European Parliament will vote soon on medical devices regulation, but a new set of amendments, which most MEPs have not had the time to assess, are being rushed through, says Serge Bernasconi.

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.

Danish 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.

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.

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.

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.

German centre-left MEP Dagmar Roth-Behrendt is proposing a centralised authority to approve medical devices before they are sold on the EU market.

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 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.

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.