Chemical characterisation of medical devices

Chemical characterisation is a process by which experts from independent bodies such as TÜV SÜD assess the health and safety risks of chemicals used in medical devices. This involves assessing properties such as a material’s chemical formulation, the purity of chemical composition, and the presence of impurities or degradants. 

The chemical characterisation of materials is an essential aspect of the regulatory review and approval of medical devices in the European Union (EU) and most major markets worldwide. Chemical characterisation is also an essential aspect of the overall biocompatibility assessment process. This helps ensure that the potential biological risks from the device and its components do not outweigh the benefits of using the device. 

By design, most medical devices perform their functions through direct contact or implantation in the body. Some medical devices have indirect contact with the body through the gas pathway (like ventilators) or blood pathways (like dialysis machines). 

This is why these medical devices should be tested to ascertain their chemical characteristics that could potentially impact the human body. Chemical characterisation may be used to identify and quantify chemical substances found in medical devices or materials that may contribute to the toxicological and biological risk management of the device. 

Conducting a chemical characterisation consistent with the requirements of EN ISO 10993-18 is a critical aspect of a manufacturer’s overall effort to verify the safety of their medical devices. Information on the chemical composition of medical devices and materials intended to come into direct or indirect contact with a patient must be provided to obtain regulatory approval in North America, Europe and other important target markets like Greater China, Japan, Korea and Singapore, as part of the biocompatibility assessment process. 

Given the complexity of the regulatory process, many device manufacturers are unaware of requirements for chemical characterisation of medical devices or don’t completely understand how the requirements apply to their devices. This can lead to interruptions in the approval process and delays in bringing their medical devices to market. 

By understanding the importance of chemical characterisation and the specifics of the process, manufacturers can help ensure the chemical safety of their devices. A thorough evaluation increases the likelihood of a smooth and efficient regulatory review process. 

TÜV SÜD is globally recognised for its quality and safety as a third-party testing provider. We have extensive experience with all types of medical devices and global regulatory requirements. 

We provide chemical testing services consistent with the requirements of ISO 10993 series, including EN ISO 10993-18 on the chemical characterisation of materials, and ISO 10993-17, which addresses toxicological risk assessment. 

Our global network of medical health and services professionals worldwide are recognised as authorities in their fields. Their collective expertise makes TÜV SÜD a trusted partner of choice for manufacturers seeking accreditations in line with medical device regulations. 

We are a comprehensive testing solution for every market you need to enter. We can customise our testing solutions to your needs, optimise your costs and minimise your time to market.