Medical devices
Brexit regulatory uncertainty ‘threatens UK med tech’
Regulatory uncertainty in the wake of Brexit could leave Britain's multi-billion-pound medical technology industry out in the cold, with separate regulatory systems threatening exports and jobs.
Parliament wants medical devices traced, scrutinised
After almost five years of talks with member states, on Wednesday (5 April), the European Parliament adopted two new regulations imposing stricter rules on medical devices’ safety.
Airlines failing to accommodate passengers in need of oxygen treatment
Airlines are unfairly discriminating against passengers that need to bring portable oxygen tanks with them on their flights. Susanna Palkonen explains the obstacles many people face.
Action for hearing loss: Make a sound investment
In March of 2017, MEPs Helga Stevens and Roberta Metsola hosted a lunch debate in the European Parliament titled, “Action for hearing loss: Make a sound investment”.
Breast implant victims win payout from German safety body
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.
Health minister: Drugs pricing will top Malta’s EU presidency
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.
Andriukaitis: Health Technology Assessment will make EU healthcare ‘sustainable’
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.
New medical devices rules should avoid ‘unnecessary’ red tape, industry says
The implementation of new rules on medical devices should avoid extra burdens and unnecessary bureaucracy, health industry officials have told EURACTIV.com.
Hearing awareness: professional hearing care makes you smarter and healthier
Around 16% of adult Europeans experience hearing loss severe enough to have a negative impact on their daily lives.
MedTech: Investing in medical technology can fix inefficiencies
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.
Parliament wants tougher medical devices control without extra burdens for SMEs
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.
Parliament wants stricter control on medical devices
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.
MEPs can make an informed decision on medical devices in Europe
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.
MEPs vote for stricter approval system for medical devices
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.
A few points that MEPs must consider ahead of medical devices vote
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.
Medical devices rules: Patients’ safety must be reinforced
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.
Danes want chemicals out of medical devices
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.
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.
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.
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.
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.
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.
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.
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.