Stay Compliant with EN ISO 10993-1:2025 Updates
Stay Compliant with EN ISO 10993-1:2025 Updates
18 February 2026
The publication of EN ISO 10993-1:2025 represents a key milestone for all medical device manufacturers who will be required, during 2026, to assess the need to update their biological evaluation documentation.
Maytal can support you in a comprehensive and structured manner to address this regulatory update efficiently and without slowing down your ongoing projects:
Gap Analysis to identify the changes introduced by EN ISO 10993-1:2025 compared to the previous version (EN ISO 10993-1:2020 / ISO 10993-1:2018)
Update of BEP and BER in full compliance with EN ISO 10993-1:2025
Integrated alignment with EN ISO 10993-17:2023 + A1:2025, optimizing time and costs through a coordinated approach
Targeted training courses on the new EN ISO 10993-1:2025, designed to ensure your Regulatory, Quality, and R&D teams are fully prepared and autonomous
Partnering with Maytal means reducing regulatory risk, anticipating Notified Body expectations, and turning this regulatory update into an opportunity for documentation optimization.
Contact us to assess the impact of the new standard on your devices and to define together the most effective update strategy.