Technical documentation section 6. Verification & validation:
6.2 Biological evaluation and biocompatibility testing
As required by Annex II, Section 6.1(c) of the MDR 2017/745, the technical documentation must include results of tests conducted to verify the biological safety of the medical device under evaluation. These tests aim to demonstrate that the materials used in the manufacture of the device, including all patient-contacting components, are biocompatible and suitable for the intended clinical use.
The biological evaluation shall be conducted in accordance with the applicable parts of the ISO 10993 series, taking into account the nature and duration of body contact. The documentation should include a rationale for the selected testing strategy, an assessment of materials used, and the results of any in vitro and in vivo studies.
Content of the documentation
- Material characterization and identification of all materials that are in direct or indirect contact with the human body
- Risk assessment of chemical, physical, and biological characteristics of materials, including leachables and degradation products
- Selection of relevant biological endpoints based on ISO 10993-1 guidance
- Summary of all biocompatibility test reports with details of test methods, results, and conclusions
- Justification for the omission of specific biological tests, if applicable
Additional considerations
In the case of devices incorporating substances that are absorbed or locally dispersed in the human body, further toxicological evaluations may be required. The results of biological testing must be critically assessed in relation to the overall risk management process and must be cross-referenced in the clinical evaluation documentation.
