When it comes to the development of Class II and III medical devices, safety isn’t just a box to check—it’s the foundation for everything that follows. At Eurofins Medical Device Services, extractables and leachables (E&L) testing is performed with meticulous care, backed by years of experience and guided by evolving regulatory frameworks. For device developers preparing for FDA review, Eurofins offers not just technical excellence, but a partner who understands the full scope of your regulatory journey.

For medical devices that come into direct contact with patients—especially those designed for long-term or internal use—chemical safety is paramount. The Eurofins Extractables & Leachables team specializes in chemical characterization studies as outlined in ISO 10993-18, helping manufacturers identify and quantify any substances that may leach from a device into the human body.

This testing is essential for meeting FDA expectations and is required for nearly every Class II and Class III device entering or modifying its path to market. Whether preparing a first submission or updating a material change, developers rely on Eurofins to deliver robust, regulatory-ready data that supports patient safety.

Unlike many labs that use a one-size-fits-all protocol, Eurofins customizes every E&L study to the unique attributes of your device. Key variables such as:

• Material composition
• Duration and type of patient contact
• Tissue interaction
• Device complexity and exposure thresholds

…all influence how testing is designed and executed.

Before testing begins, the Eurofins team performs a pre-evaluation to ensure the solvents selected won’t degrade or swell the material. This early assessment helps prevent costly rework and ensures your data will hold up under regulatory scrutiny.

One of the biggest pain points in E&L testing is timing. Testing must be done late enough in development so that materials and manufacturing processes are final, but early enough that there’s still room in the schedule for regulatory review and approval. With studies often taking 3–6 months (including toxicological risk assessment), hitting that window is crucial.

Another challenge is determining detection thresholds. The type of device and its patient exposure level dictate how low results must be detected and reported. The lower the threshold, the more complex the analysis—and the more device samples required. For products still in development, even sourcing enough devices for testing can be difficult.

Thanks to years of working with diverse device types and polymer compositions, Eurofins brings a rare level of predictive insight to the table. “We can often anticipate what’s likely to show up in the extractables profile before we even run the tests,” said Katie, one of the lab’s senior experts. “That means we can reach conclusions faster and reduce the risk of unexpected surprises later.”

One of the most significant advantages of working with Eurofins is their responsiveness to regulatory evolution. In a recent example, the team completed a study just weeks before a new draft guidance was released. Because of their ongoing awareness of pending changes, they were able to align the study with anticipated standards—ensuring the customer’s submission remained viable despite the shifting regulatory landscape.

While several labs offer E&L testing, few offer the agility, customization, and turnaround times of the Eurofins Extractables & Leachables team. Their approach is rooted in:

• Fast, reliable timelines designed around your development cycle
• Tailored protocols based on your exact materials and risk profile
• Proactive solvent assessments to avoid data-compromising material reactions
• Expert interpretation of regulatory guidance and industry standards

In a field where precision can mean the difference between approval and delay, Eurofins delivers the peace of mind that comes with experience.

If you’re developing a Class II or Class III medical device, extractables and leachables testing isn’t optional, it’s essential. Eurofins offers a comprehensive, custom-tailored approach to chemical characterization studies, supporting you from early planning through submission.

Contact us today to learn how our team can help you meet your testing requirements with confidence, speed, and scientific integrity.