As 2025 comes to a close, many quality teams are already starting to look ahead to what 2026 will bring and how best to prepare for it. Let’s take a closer look at the most significant changes to prepare for early in the year.
U.S FDA QMSR will come force on 2 February 2026. Harmonization is the goal, but ISO 13485 certification alone is not enough to ensure FDA compliance.
In Europe, four EUDAMED modules become mandatory in May 2026.
At the same time, the phased implementation of the AI Act is reshaping expectations for AI-enabled and software-based devices both in medical and general devices, bringing new requirements that influence documentation and post-market practices.
For health tech companies, early preparation will make a real difference as regulatory expectations continue to evolve.
Useful links:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202502371