In Vitro Diagnostics

Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.

As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.

EU medtech trade associations present detailed arguments for the European Commission’s 'targeted evaluation' of medtech regulations, highlighting the need for immediate course correction.

The EHDS’ pivotal role in generating real-world evidence and capturing patient-reported outcomes will be a bonus for health technology assessment, especially in digital health.

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.