Toxicological Risk Assessment (TRA) for Medical Devices

Chemical safety must be supported by robust evidence to place medical devices on the European market. Sobel’s Human Safety team develops Toxicological Risk Assessments (TRA) aligned with EU MDR and ISO 10993 expectations.

For who?

Sobel delivers a toxicological risk assessment TRA aligned with ISO 10993-1, ISO 10993-17, and ISO 10993-18, integrating scientific evidence with regulatory expectations.

Why do you need this service?

Under the EU MDR, manufacturers must demonstrate that no unacceptable chemical risks exist as part of the biological evaluation.

A toxicological risk assessment evaluates identified substances, defines exposure limits, and assesses whether associated risks are acceptable for the intended use of the device.

A robust TRA strengthens your biological evaluation, supports smoother Notified Body review, and reduces the likelihood of objections, requests for additional data, or delays in CE marking.

Turning chemical data into defensible safety conclusions

Our approach focuses on relevance, traceability, and transparency — ensuring that toxicological conclusions are clearly linked to chemical characterization data, clinical context, and intended use.

Chemical safety assessment that supports regulatory confidence.

Review of chemical characterization

Assessment of identified and quantified device constituents based on chemical characterization conducted in accordance with ISO 10993-18.

Toxicological data assessment

Collection and evaluation of existing toxicological data for substances and materials, including publicly available literature and relevant proprietary sources.

Exposure and limit definition

Definition of tolerable intake values, exposure limits, and safety margins based on intended use, exposure duration, and patient population, in line with ISO 10993-17.

Risk evaluation and acceptability

Assessment of identified risks against established criteria to determine acceptability and identify the need for additional testing or risk control measures.

Clinical use and exposure context

Analysis of data related to clinical history of use of the device, reference devices, and human exposure to relevant substances.

TRA reporting

Preparation of a structured Toxicological Risk Assessment report suitable for inclusion in technical documentation and biological evaluation files.

Related
Services

A toxicological risk assessment (TRA) is not a standalone exercise. Under the European regulatory framework, chemical safety must be supported by complementary evaluations and documentation, which Sobel also supports through integrated regulatory and scientific services, such as:

Internal Audits

Internal audits supporting ISO 13485 compliance and notified body readiness in Europe.

CE Mark Regulatory Support

Gap analysis, technical documentation, and ongoing regulatory for CE Mark for Medical Devices.

Biological Evaluation (BEP, BER)

Expert biological evaluation services. BEP, BER, Gap analysis, and regulatory support.

Toxicological assessments that support confident CE marking

A well-executed toxicological risk assessment TRA is essential to demonstrate chemical safety and support compliance under the EU MDR.Sobel combines toxicological expertise and regulatory understanding to deliver assessments that are scientifically robust, clearly documented, and aligned with Notified Body expectations.

Still have questions? Checkout our FAQ

1. What is a Toxicological Risk Assessment (TRA)?

A Toxicological Risk Assessment (TRA) is a structured scientific evaluation that assesses whether chemical substances released from a medical device pose unacceptable risks to patients or users. In the European context, the TRA supports the biological evaluation required under Regulation (EU) 2017/745 (EU MDR) and is guided by the ISO 10993 series.

2. When is a Toxicological Risk Assessment required under the EU MDR?

A TRA is required when chemical characterization identifies substances that may be released from a medical device and require toxicological evaluation. It forms part of the biological evaluation to demonstrate that no unacceptable chemical risks exist for the intended use of the device.

3. Which standards apply to Toxicological Risk Assessment in Europe?

TRA activities are guided primarily by ISO 10993-1, ISO 10993-17, and ISO 10993-18. These standards define how chemical characterization data are generated, how exposure limits are established, and how toxicological risks are assessed and documented.

4. Is a TRA required for all medical devices?

Not necessarily. The need for a TRA depends on factors such as device materials, nature and duration of body contact, chemical characterization results, and intended use. When substances are identified that require toxicological evaluation, a TRA becomes necessary.

5. How does a TRA differ from chemical characterization?

Chemical characterization identifies and quantifies substances released from a device, typically in accordance with ISO 10993-18. A TRA evaluates the toxicological relevance of those substances, defines exposure limits, and assesses whether the associated risks are acceptable.

6. Can existing toxicological data be used in a TRA?

Yes. A TRA relies heavily on existing toxicological data from scientific literature, databases, and relevant proprietary sources. New testing is considered only when existing data are insufficient to support a robust risk assessment.

7. Does a TRA replace the Biological Evaluation Report (BER)?

No. A TRA does not replace the Biological Evaluation Report. It supports the biological evaluation by providing toxicological conclusions related to chemical safety, which are then integrated into the BER.