Medical devices
In vitro diagnostics regulation to be progressively rolled out amid delays
The European Commission has proposed a progressive roll-out of the regulation on in vitro diagnostic medical devices in a bid to fight shortcomings. However, MEPs criticised the lack of notified bodies to assess their conformity and the delays of more than a decade in their application.
EU ‘bureaucracy’ risks hampering life-saving medical devices, MEP warns
The EU’s strict approval procedure for medical devices must temporarily be relaxed during the COVID-19 outbreak in order to allow ramping up production of vital equipment such as ventilators, a German lawmaker in the European Parliament has warned.
EU health sector ‘up to a decade’ behind others for digitalisation, Commission says
The EU health sector is in the middle of a defining moment but the sector is “up to a decade” behind other sectors in terms of digitalisation, Deputy Director-General for Health and Food Safety Martin Seychell told EURACTIV.com.
Better access to health innovation is Kyriakides’ top priority (and hardest task)
With increased powers, Health Commissioner-designate Stella Kyriakides is tasked with striking a difficult balance between making sure there is a steady supply of affordable medicines and ensuring that EU pharma industry remains a world leader in innovation.
Katainen: Same level of priority for food and medicine in no-deal Brexit
Medicine supplies and food safety standards are both vital and the EU cannot prioritise one over the other in the event of a no-deal Brexit, Vice President of the Commission Jyrki Katainen said on Thursday (4 April).
Pharma industry urges EU leaders to ‘re-focus’ on patients post-Brexit
The EU pharma industry has prepared for a hard Brexit scenario but this is not enough as EU leaders need to take specific measures to ensure medical supplies after the UK departure, EU pharma chief Stefan Oschmann has said.
Trade secrets called into question in ‘Implant Files’ investigation
The French transposition of the European directive on trade secrets has hindered access to certain documents required for the “Implant Files” investigation. EURACTIV France reports.
“Time is Brain”: How ERDF funds save lives in Berlin
The most comprehensive EU regional development instrument is the European Regional Development Fund (ERDF). But in most cases, its work remains largely unknown to the public. An example from Berlin shows how it literally saves lives. EURACTIV Germany reports.
Commission reassures ‘worried’ member states on Health Technology Assessment
The Commission’s upcoming proposal on Health Technology Assessment (HTA) will focus on clinical aspects and leave member states to decide on economic or ethical parts, a European Commission spokesperson told EURACTIV.com.OpinionPromoted content
Silicones – enabling the next big leap in prosthetics and health
Prosthetics have been used for hundreds of years, but for much of that time saw little to no technological development. They were heavy, single-purpose, unattractive and, in many cases, unhygienic.
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. VideoPromoted content
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. VideoPromoted content
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.