ADVERTISEMENT
In Vitro Diagnostics
Existing legislation already offers a route, albeit rarely used, for orphan and innovative devices to reach the market more quickly. It should be used more; manufacturers and notified bodies do not need to wait for official changes to the EU’s medtech regulations.
If medtech becomes embroiled in the EU-US trade war, access to critical and innovative medical devices will be under threat.
The European Commission has published a 44-page EHDS Q&A while industry has issued a joint paper emphasizing the importance of a stakeholder forum just as the EHDS Regulation is published and is due to enter into force.
In the wake of a series of unprecedented executive orders from US President Trump, the EU medtech industry faces significant political, regulatory and business challenges. Swift and strategic action is essential to ensure stability and safeguard patient safety.
Are you selling a high-risk AI-enabled device or service? Understanding the next steps is crucial. A team of legal experts has shared valuable advice to help you start to understand the complexities.
In the wake of a series of unprecedented executive orders from US President Trump, the EU medtech industry faces significant political, regulatory and business challenges. Swift and strategic action is essential to ensure stability and safeguard patient safety.
EU industry advocates for amendment to existing proposal to streamline clinical strategy costs and timelines, as well as boost efficiency and innovation
As the EU AI Act takes shape, critical details are emerging rapidly. However, the approaching deadlines are even more pressing. This article delves into the essential information that medtech professionals need to stay ahead.
The Irish notified body has had to suspend IVD client work since late 2024.
During Q4, biopharma merger and acquisition deal value reached $9.4bn and drew in $72.8bn in potential deal value from alliances. Device company M&A values reached $395m, while in vitro diagnostics and research tools players’ M&A activity totaled $604m.