As we welcome 2026, we take a moment to reflect on a meaningful year for confinis.
2025 was a year of growth, connection, and important milestones.
We proudly celebrated 20 years of confinis during a memorable retreat in Saanenmöser, Switzerland, a moment to reflect on our journey and the people who made it possible!
Throughout the year, our team came together onsite in Switzerland in February, August, October and December, strengthening collaboration and shared purpose.
We also entered an exciting new chapter by joining the Athagoras Group and moving into our new office in the heart of Basel.
From a regulatory perspective, 2025 was equally significant for MedTech manufacturers and combination products, with key developments shaping the landscape:
🟥 Initial EU AI Act obligations beginning to apply
🟥 MDR/IVDR extended transition periods moving into active enforcement
🟥 The FDA experienced layoffs and a general hostile internal policy
🟥 Greater clarity around UDI requirements for combination products
Looking ahead to 2026, regulatory expectations will continue to evolve:
🟥 AI Act high-risk obligations and PMS enforcement will intensify scrutiny across the EU
🟥 FDA QMSR compliance will become mandatory. while the capacity of the agency to carry on its work will be at its history minimum
🟥 Real-world data will play an increasingly central role in regulatory decision-making
🟥 IVDR compliance will start to ramp up as a leading topic for manufacturers
In a world dominated by uncertainty, we remain committed to supporting our partners with clear, pragmatic strategies that span from pure Regulatory and Quality topics to more strategic Pricing, Market Access, Reimbursement and Evidence Generation via our partnership with the IGES Institut GmbH IGES Pharma. Now more than ever, we want to help innovations move responsibly from development to market, and beyond.
Wishing our clients, partners and colleagues a successful, thoughtful and prosperous 2026.
We look forward to continuing the journey together!
While you focus on innovation, we take care of the regulatory path!
