Course objective and outcome

The objective is to give participants an understanding of their obligations regarding justification of chemical safety of their devices - and how to tackle these obligations.

The course will give the overall framework in relation to determining the chemical safety of medical devices. The focus will be on regulatory requirements, chemical testing and chemical safety evaluation using toxicological information obtained from literature searchs. The course will provide you with a structured and cost-effective strategy to guide you through the process of obtaining sufficient justification for the chemical safety of your device using illustrative examples. These considerations are relevant for selection of materials in product development, device registration and changes to materials/suppliers.

Content

The course will use illustrative examples to give you an understanding of:

• Regulatory introduction: Starting from the MDR legal requirements to the technical requirements of ISO standards
• The new ISO 10993-1:2025 and its impact on the ISO 10993-18 chemical characterization strategies
• Parallelism between EU legal requirements with US FDA requirements - how chemical characterization strategies are changing
• Other regulatory areas to consider: REACH, SVHC, RoHS, etc.
• How to obtain the relevant chemical information for your device
• How to decide when testing is necessary
• How to make a strategy for chemical testing & reduce time to market
• How to perform chemical testing and understand how to choose among various methods
• How to assess the safety of chemicals in your device based on toxicological information
• Where to find relevant information for the safety assessment 
• How to address bioaccumulation from a chemical perspective
• Dealing with PFAS – what is the status in the medical device safety assessment

Cases will be presented and used for discussions during the course.
 

Who should attend?

The course is relevant for all employees of medical device companies who would like to be introduced to aspects regarding chemical compliance of medical devices. It is suitable for both those with no in-depth knowledge and for more experienced employees, as it clarifies key aspects of chemical characterization and provides insights into the latest advancements in the field.

Trainer

Daniele Lioi, Senior Consultant – Medical Devices and Business Unit Manager Eurofins

What previous participants said

"Good balance of overall introduction and in depth and detailed presentation"

"The course gave a very good overview of chemical testing requirements"

"Liked the content and the teacher"