BIOCOMPATIBILITY MORNING: ISO 10993-1:2025 – Key Changes, Notified Body Expectations, and Implementation Challenges

BIOCOMPATIBILITY MORNING: ISO 10993-1:2025 – Key Changes, Notified Body Expectations, and Implementation Challenges

During the Biocompatibility Morning Complife & BSI experts will provide a practical overview of the key changes introduced in the new edition of ISO 10993-1:2025 and their implications for the biocompatibility evaluation of Medical Devices.

Date

20 May, 2026

Location

Bologna, NH Hotel De La Gare

Registration Deadline

13 May, 2026

Format

In person

Language

Italian

Price

€50
(VAT excluded)

Registrations closed

In collaboration with the Notified Body BSI Group, in this event we will provide practical insights into the key changes introduced in ISO 10993-1:2025 and what they mean for biological evaluation strategies, together with a brief update on further developments currently under discussion within ISO/TC 194 – responsible for updating ISO 10993 series – and expected over the coming year.

The session will conclude with an interactive fireside chat, offering attendees the opportunity to engage directly with the speakers and discuss practical questions.

Key Points

Key updates of ISO 10993-1:2025
Notified Body expectations & reviewer perspective
Risk-based approach & ISO 14971 integration
Practical impact on manufacturer strategies
Interactive discussion & real-case insights

Details

Welcome 9.30 AM
2,5-hour session (10.00 AM – 12.30 PM)
Mid-morning Networking coffee
Event with limited availability – 25 places
Certificate of participation

In-person, NH Hotel De La Gare, Bologna