Day Three – 12 June 2024Wednesday, 12 June 2024 - CEST (Cent Europe Summer, GMT+2)

The revised draft of the new Part 1 has brought about multiple changes so join us as we discuss its effects on the biological evaluation process.

• Overview of biological risk assessment per ISO 10993-1:2018
• What’s on the horizon for biological risk assessment per revisions that are currently under discussion
• Illustration of biological safety evaluation using a true risk assessment approach through a case study

• Proper study design and thorough planning that considers device-specific intricacies in sample preparation is crucial for a successful biological evaluation. Improper sample preparation or extraction conditions can lead to additional evaluation time, testing costs, and animal use.

  In this session, we will discuss some of the main contributing factors associated with:

  • Improper test article preparation.

  • Improper extraction conditions.

With the recent updates and newly revised ISO 10993-1, join us in discussion as we navigate the anticipated effects of these regulatory changes.

• Revieing New Approach Methodologies (NAM)
• Identifying the various types of sensitizers that leach from medical devices
• Data initiatives tox reports and literature

• Dissecting and explaining the requirements of MDR GSPR 10.4

• Examples of hazardous substances

• Determination whether hazardous substances are present above 0.1% w/w

• To Do’s when hazardous substances are present above 0.1% w/w

• Meeting regulatory expectations in biocompatibility testing for medical devices

• Biocompatibility challenges during MDR certification of legacy devices.

• Addressing the “gap’ between regulatory expectations and industry practices