Biotechnology sponsors entering Europe are facing a quieter but more important access shift than many realise. It is easy to describe this shift as procedural. The European Union has introduced …

Why diagnostic readiness is becoming the next rare disease access barrier For decades, rare disease screening has been shaped by a cautious principle: do not test for a condition unless …

From national evidence to regional care When Sweden issued a national recommendation for Automated Insulin Delivery systems in adults with type 1 diabetes, the headline could easily have been read …

Clinical evidence is becoming more coordinated. Reimbursement is not. Europe is often described as one of the great prizes for high-risk MedTech and IVD companies. In one sense, that is …

For many MedTech, IVD, digital health, biotech and pharmaceutical companies, the difficult question is no longer simply whether a technology can reach the market. Regulatory approval remains essential. A CE …

Why the best first market is not the biggest one, but the place where value becomes visible fastest Ask a MedTech, IVD, AI or digital health company where it wants …