Biological Evaluation Study

Medical Device Manufacturers are responsible for proving that their medical devices do not cause tissue damage when in contact with tissue. In this regard, a Biological Evaluation Study should be conducted based on the EN ISO 10993-1 Standard.

This process is often perceived by Medical Device Manufacturers as conducting Biocompatibility Testing. However, with the Biological Evaluation Study, the manufacturer assesses which tests from the EN ISO 10993-1 standard, as specified in Table A.1 of the standard, need to be conducted based on factors such as the tissues their products come into contact with, the contact duration, and the structure of the products. The manufacturer makes decisions based on this and, if necessary, conducts biocompatibility tests to support the biological compatibility of the products.

By conducting the biological evaluation study correctly, the manufacturer can avoid high test costs, which, although not mandatory, may arise. This also helps to prevent the loss of many laboratory animals that might have been used in testing.

The biological evaluation process should be carried out based on Annex B and Annex C of the Standard. The evaluation must include the following topics:

• Physical and chemical characteristics of materials intended for use;
• Historical clinical use and human exposure data;
• Any available toxicological and other biological safety data related to product and component materials, degradation products, and metabolites;
• Experimental procedures;
• Manufacturing materials/materials;
• Designed additives, process contaminants, and residues from raw materials to the final product;
• Leachable substances;
• Degradation products, if any;
• Other components and their interactions in the final product;
• Performance and characteristics of the final product;
• The physical characteristics of the final product, including but not limited to porosity, particle size, shape, and surface morphology.