Medical Device

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

Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

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.

Zydus Lifesciences plans to expand global markets for patented products of French orthopedic tech company Amplitude Surgicals which it is acquiring from PE firm PAI Partners and others. Could the European business also serve as a buffer to upheaval in the US amid talks of tariffs?

Zydus Lifesciences plans to expand global markets for patented products of French orthopedic tech company Amplitude Surgicals which it is acquiring from PE firm PAI Partners and others. Could the European business also serve as a buffer to upheaval in the US amid talks of tariffs?

Teva will have to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March, as the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

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.