Toxicological risk assessment (TRA) is one of the most critical, and often most misunderstood, steps in medical device development. Whether you're preparing a 510(k), PMA, or EU MDR submission, a toxicological risk assessment is essential to prove the biological safety of your device. The problem is that many manufacturers aren’t sure when to commission a toxicological risk assessment, or what to do if an “unknown” emerges late in the process.

The Eurofins Medical Device Services network of laboratories helps you plan, execute, and complete your toxicological risk assessment with confidence. Our qualified toxicologists assess extractables, leachables, and other chemical constituents to establish safety thresholds in line with ISO 10993, FDA, and MDR expectations and follow a structured, science-driven process:

• Dose–response assessment considering patient populations
• Exposure assessment based on product design and use
• Hazard identification and data evaluation
• Risk characterisation that leads to safety conclusions and regulatory clarity

Toxicological risk assessments are often required as part of a chemical characterisation study, especially when extractables or leachables are identified during material testing. In these cases, a thorough toxicological assessment will determine whether the compounds pose a risk to patient health and what action, if any, must be taken.

If a substance is poorly characterised or entirely “unknown,” our team will investigate further, drawing on a wide range of toxicology expertise and experience and, if necessary, additional testing to bridge data gaps. Anticipating and identifying these issues early reduces the risk of delays and repeat testing.

Summary of our Toxicological risk assessment Process

• Designed to meet submission needs for FDA and MDR
• Integrated into your ISO 10993-17 and ISO 10993-18 strategy
• Performed by qualified toxicologists with EU and US regulatory expertise
• Supports product development, validation, reprocessing, and sterilisation

Eurofins Medical Device Services offers full-service support for medical device manufacturers of every size, from startups seeking help with their first regulatory submission, to large global manufacturers navigating material changes and revalidations. We work with you to:

• Deliver ready-to-submit reports aligned with biocompatibility testing
• Ensure your device meets regulatory expectations and timelines
• Identify and mitigate potential toxicological risks
• Prepare your toxicological risk assessment

Whether you’re responding to findings from extractables and leachables testing, updating your chemical characterisation data, or building a comprehensive biological evaluation plan, our experienced toxicologists at Eurofins Medical Device Services provide a trusted, proven approach to toxicological risk assessments.