EU Legislative Reform

We do not want the commission to wait for its targeted evaluation before making regulatory changes to the MDR and IVDR, medtech industry representatives tell Galway meeting. They shared their vision of what could happen next.

The EU’s health nominee may not be as controversial as the recent US one, but the candidate being grilled has proved the least popular of the commissioner nominations with MEPs

Increased staffing would enable the commission's device unit to drive urgent regulatory changes more quickly, leading cardiologist Alan Fraser tells Galway meeting

The EU’s health nominee may not be as controversial as the recent US one, but the candidate being grilled has proved the least popular of the commissioner nominations with MEPs

Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?

Medtech engineering association shares concerns over regulations, innovation and EU competitiveness with remainder of medtech industry.

The EU medtech regulations are being targeted for change, with many amendments being critical for the sector and patients. Ireland’s Niall MacAleenan explained why tackling governance is the most critical part of this at a recent meeting in Galway.

Behind the scenes, there were many conflicting, but also useful discussions, which ultimately shaped the message the European Parliament delivered to the European Commission in late October about the need for changes to the Medical Device and IVD Regulations.

As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.

Those working in the medtech sector returned from their traditional August break to a growing sense that the EU is more collectively aligned about the need to improve the medtech regulations and soon.