EU IVDR Amending Regulation Published And Staggered Grace Periods Now Official

IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.

The ceramic device, designed to reduce complications, will be exclusively distributed by Zimmer Biomet and initially available in 30 hospitals, with broader European access expected by 2026.

Amendments to Germany’s – barely in force – health reform law will be decided after the summer break. The new DRGs payments plan and service groups will be reviewed, but critics fear for the law’s future.

Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.