Chemical characterisation is no longer a check box exercise. For today’s medical device developers, extractables and leachables (E&L) testing plays a critical role in risk mitigation, regulatory submission, and avoiding costly setbacks later in development. But for many small to mid-sized manufacturers, this stage is riddled with uncertainty. What testing do I really need?

The Eurofins Medical Device Services network of laboratories provides the clarity, speed, and scientific expertise you need to move forward with confidence. Our ISO 17025-accredited facilities, staffed by 100 dedicated E&L scientists, offer more than 30 years of experience and access to more than 500 advanced HPLC and GC systems. 

Important phases in your product development lifecycle that may require E&L assessments include:

• Developing new product design concepts 
• Performing verification testing for your design history file  
• Changing raw material suppliers 
• Implementing design or manufacturing process changes 

From protocol design to toxicological risk assessment, we support you every step of the way. We will work with you to:

• Determine the most appropriate test conditions for your device 
• Select the right solvents and extraction methods 
• Perform exhaustive or exaggerated extractables studies (ISO 10993-18) 
• Conduct simulated-use or leachables testing based on real-world exposure 
• Identify compounds using our proprietary spectral database of more than 1,500 non-volatile substances 
• Perform toxicological risk assessments (ISO 10993-17) with reports ready for regulatory submission 

Our coordinated E&L packages, often delivered in parallel with biocompatibility testing,  compress timelines and reduce the risk of late-stage issues. With direct access to our expert toxicologists, your project will benefit from real-time troubleshooting, guided decisions, and clear justifications for regulatory authorities.

• One unified workflow for E&L, toxicology, and biocompatibility 
• Dedicated project manager and expert point of contact 
• Risk assessments aligned with FDA guidance and ISO 10993 standards 
• Support during changes to raw materials, suppliers, or manufacturing processes 

Whether you're launching a new product, submitting a 510(k), or responding to a regulatory query, our goal is to help you uncover any potential issues before they become costly complications.

The responsive, reliable, and accessible teams within Eurofins Medical Device Services  ensure your E&L project stays on track, on time, and on budget.