The Life Sciences Innovative Manufacturing Fund, set out in the UK budget last month, is live for applications. More UK medtechs would benefit if the cost threshold were scaled down, the industry argues.
The European Commission has issued a draft document setting out the potential conditions for joint HTA scientific consultations on medical devices taking place in parallel with consultations with an expert panel.
Device supply interruptions and withdrawals, now common in the EU, could threaten patient safety. Newly issued manufacturer guidance from the European Commission is intended to improve transparency and minimize disruption.
UK chancellor of the exchequer Rachel Reeves said her 2024 budget announcement would address the problem of ‘hospitals being without the equipment they need.’
European cross-country HTA collaborations have much to learn from each other to keep prices from rising unfairly, Nordic health technology assessment experts say, adding that talks on collaboration are also ongoing with HTA bodies outside the continent.
The European Parliament is making a formal appeal to the European Commission to accelerate its EU MDR revision plans.
Findings of Germany’s latest annual survey of medtech opinion and business confidence are a wake-up call for European industry and heap further criticism on the EU MDR.
The second of six implementing acts for the Health Technology Assessment Regulation has now been adopted. It deals with how the European Medicines Agency is to cooperate with the European Commission and HTA experts in Europe.
An agreement between the EU and Switzerland potentially opening the way for renewal of the MRA – enabling barrier-free cross-border medtech trade – could be concluded as early as December. More good news for Switzerland, relating to the acceptance of FDA-approved products into the country, could follow in Q1 2025.
‘Unicorn’ Startup Owkin On EU’s AI Act, Funding Needs: ‘Europe Doesn’t Want To Be Under-Competitive’
The EU Artificial Intelligence Act, the first official AI regulation globally, entered into force on 1 August 2024. Two months on, Medtech Insight sits down with AI diagnostic startup Owkin’s chief diagnostic officer Meriem Sefta, and senior vice president of public affairs and impact Yedidia Levy-Zauberman, to discuss how the company is adapting to the EU AI Act, the opportunity it presents, and what is needed next for AI deployment in the EU.
The European Parliament wants the European Commission to revise the Medical Device Regulation within 100 days. But EU member state authorities warn of the consequences of rushing matters.
The public alongside clinicians and industry experts is asked to submit ideas for reforming the NHS via a dedicated online platform ahead of the new NHS Plan in 2025.
“Flying blind” into healthcare reform was among the feisty criticisms of Germany’s proposed law on hospital care improvement during the final parliamentary plenary on 17 October. SPD health minister Karl Lauterbach has stoutly defended his reform.
The problems besieging the EU medtech industry are already too serious and in need of urgent remedy to wait any longer for change, industry says in open letter to the European Commission.
The Design for Life roadmap will help medtech companies comply with the UK NHS’s Net Zero 2045 greenhouse gas emissions target. A dedicated medtech innovation center is mooted.
Speakers focused on whose role it is in the EU to support manufacturers who struggle to interpret the medtech regulations.
European Commission acts on call from industry for more guidance from notified bodies around innovation.
A new UK medtech survey sets out industry’s market access and regulatory concerns and makes clear where system users see the need for improvement. There are some grounds for optimism, but the MHRA’s planned rise in regulatory fees could undo some of the good work.
Achieving a balance between regulatory controls and promoting innovation is proving one of the biggest challenges that the EU is facing since the implementation of the MDR and IVDR. But there are ways through.
Tricuspid valve innovation has taken off since the US FDA’s 2023 authorizations of Edwards' Evoque and Abbott's TriClip systems. Whether to repair or replace tricuspid valves remains an open, nuanced question among cardiologists. Dr. Henrik Treede of University Hospital Mainz and TriCares CEO Ahmed Elmouelhi offer views on the evolving space.