Toxicological studies of medical devices

The main task of toxicological studies is to prove that the materials and components of the product do not have harmful effects on the human body when used for its intended purpose. Such studies are required for most medical devices that come into contact with skin, mucous membranes, blood, or internal tissues. It is impossible to obtain a registration certificate without the results of a toxicological assessment, since the regulator must ensure that the product is safe for the patient and medical personnel. This type of research is a mandatory part of the registration of a medical device. 
The scope of research is determined by the purpose of the product, the duration and nature of contact with the body, as well as its risk class. During the tests, possible chemical and biological risks are assessed. The composition of materials and released substances is analyzed, their toxicity and potential effects on cells and tissues are determined. Depending on the type of product, cytotoxicity, irritant and sensitizing effects tests can be performed, as well as studies of systemic toxicity and compatibility with blood. For implantable and long-term used products, the scope of research is expanding, as deeper confirmation of biological safety is required.
The toxicological assessment is carried out in accordance with current standards for the biological assessment of medical devices, including GOST ISO 10993 series standards. These documents establish approaches to the selection of studies, their methods and interpretation of the results. The tests must be performed in accredited laboratories authorized to conduct the appropriate types of research. The protocols are drawn up according to the established requirements and are included in the registration dossier. When registering under the rules of the Eurasian Economic Union, the status of the laboratory as an authorized organization is also taken into account.
In practice, it is the toxicological stage that often requires careful preparation. Errors in the selection of the test volume, non-compliance of the research program with the requirements of standards, or incorrect design of protocols may lead to requests for revision or the need for repeated studies. Therefore, it is important to determine the list of necessary tests in advance and ensure proper interaction with the laboratory.
The results of toxicological studies directly affect the possibility of registering a medical device. Confirmation of biological safety is a prerequisite for the product's admission to the market. In the absence of the necessary data or when risks are identified, the regulator has the right to suspend or refuse registration.