Evaluating the biological safety of a medical device is a critical step in development—one that directly impacts regulatory approval, project timelines, and patient safety. From early material selection through final submission, understanding how a device interacts with the body requires careful planning, scientific expertise, and alignment with evolving regulatory expectations. Yet many device manufacturers underestimate the scope of this work, leading to delays, unexpected findings, and added cost.

The process begins with a comprehensive Biological Evaluation Plan (BEP) developed in accordance with ISO 10993-1. The BEP establishes the biological evaluation strategy based on the device’s intended use and associated risks and identifies the assessments necessary to support biological safety. Depending on the device and its characteristics, the evaluation may include biocompatibility testing, extractables and leachables (E&L), and toxicological risk assessment (TRA).

Regulatory expectations continue to evolve, including increased scrutiny on chemical characterization(e.g., E&L) data. Without a clear strategy in place early, teams may face challenges such as unexpected results, additional testing requests, or difficulty interpreting complex data sets.

Eurofins Medical Device Services network of laboratories works with manufacturers to bring clarity and structure to biological safety programs. By combining consulting with laboratory testing, we help teams define the most appropriate  studies, anticipate regulatory expectations, and generate data that supports a submission with confidence. Our experts guide study design, interpret results, and address challenges as they arise—including unexpected findings or refining testing strategies.

Our global network provides expertise across key biological safety disciplines, including:

• Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) development
• Biocompatibility testing aligned with ISO 10993-1 and FDA’s Guidance on ISO 10993-1
• Toxicological Risk Assessment (TRA) 
• Extractables and Leachables (E&L) studies and chemical characterization
• In vitro and in vivo testing aligned with advanced analytical capabilities

All testing is conducted under GLP and ISO 17025 quality systems, for reliable data that meets global regulatory requirements. For complex devices, novel materials, or combination products, we develop tailored study approaches and provide insights to help device manufacturers respond to new questions or changing requirements.

We support organizations at every stage—from early development through post market submission—adapting to different levels need. Whether you are building a biological safety strategy or addressing a specific challenge, Eurofins Medical Device Services network of laboratories provides the expertise, responsiveness, and coordination needed to keep your medical device moving forward.

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