Toxicological Risk Assessment
If you intend to place a medical device on the European market, it is essential to demonstrate safety and compliance through robust scientific evidence. A robust Toxicological Risk Assessment (TRA) is a key part of your biological evaluation, required by the Medical Device Regulation (MDR – EU 2017/745) and guided by the ISO 10993 series.
Our expert-led TRA Toxicological Risk Assessment service helps manufacturers build a strong, defensible case for the biocompatibility and chemical safety of their devices—supporting faster CE marking and reducing the risk of regulatory pushback.
How We Support Your EU Compliance Strategy
Our team delivers a complete, evidence-based toxicological risk assessment that integrates seamlessly into your Biological Evaluation Report (BER) or Clinical Evaluation Report (CER). Here’s how we work:
Review of Chemical Characterization (EN ISO 10993-18): We assess all identified and quantified device constituents, focusing on substances eligible for toxicological review.
Use of Existing Toxicity Data: We gather publicly available and proprietary data to evaluate each substance’s toxicological profile—including potential carcinogenic, mutagenic, and reproductive effects.
Defining Exposure Limits: We calculate values based on the device’s intended use, exposure duration, and patient population.
Risk Acceptability Determination: Risks are assessed using a structured, criteria-based approach to determine whether additional testing or risk control measures are needed.
Strategic Documentation: We provide a complete TRA report ready to be included in your technical documentation, supporting a smoother Notified Body review.
Throughout this process, we take into account real-world exposure data, clinical history, and toxicological relevance to support a well-rounded evaluation.
Why do you need this service?
Under the MDR (EU 2017/745), a Biological Evaluation must demonstrate that no unacceptable chemical risks exist. Our TRA meets the requirements of ISO 10993-1, ISO 10993-17, and ISO 10993-18, providing the toxicological evidence you need for your CE marking submission.
A proper TRA identifies potentially harmful substances. We assess their toxicological impact and help you prove that the risk is controlled—or provide strategies to mitigate it.
A well-structured TRA not only supports your biological evaluation but also builds confidence with Notified Bodies, helping you achieve CE marking faster and with fewer objections.
Launching a medical device in Europe requires more than just innovation—it demands clear proof that your product is safe for its intended use. A well-structured Toxicological Risk Assessment is essential for your success!
Need support with your toxicological risk assessment in the European Union?
A complete Toxicological Risk Assessment is your passport to compliance, safety, and successful CE marking. With our scientific and regulatory expertise, we help ensure that your documentation meets MDR expectations from the very beginning.
Reach out today and let Sobel guide your product toward successful entry into the European market—with safety and compliance at the core.
