For medical devices with direct or indirect contact to patients the biocompatibility is an important feature which needs to be verified within the safety checks. Extensive laboratory tests check the suitability of the products for the respective intended use.

Thus, biocompatibility is mentioned several times in MDR/IVDR. The ISO 10993 series of standards define in detail the requirements for the respective devices. Furthermore, the corresponding risks need to be evaluated in the risk analysis. Therefore, its first part is named: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Furthermore, the new ISO 18562 series concerning the biocompatibility of breathing gas pathways in healthcare applications has been published since 2017.