Chemical Characterisation of Medical Devices

WHAT IS CHEMICAL CHARACTERISATION OF MEDICAL DEVICES

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 specifics of the chemical characterisation process and the importance of chemical characterisation in the overall evaluation of medical device safety, manufacturers can take the proper steps to help ensure the chemical safety of their devices.

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, which helps ensure that the potential benefits of using a given medical device are not outweighed by the potential biological risks associated with that device or its components or materials.

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.

The chemical characterisation process uses various evaluation methods, such as microscopic and spectroscopic analysis, x-ray diffraction, and chromatography. These and other techniques can provide detailed information regarding a material’s chemical formulation, the purity of chemical composition, or the presence of impurities or degradants.

THE IMPORTANCE OF CHEMICAL CHARACTERISATION

The importance of evaluating the potential health and safety risks associated with the chemicals used in medical devices cannot be overstated. 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 for the device.

CHEMICAL CHARACTERISATION FOR MEDICAL DEVICE APPROVAL

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.

ENSURE THE CHEMICAL SAFETY OF MEDICAL DEVICES

Conducting a chemical characterisation consistent with the requirements of ISO 10993-18 is a critical aspect of a manufacturer’s overall effort to verify the safety of their medical devices. A thorough evaluation of the chemical safety of device components and materials can increase the likelihood of a smooth and efficient regulatory review process.

Why choose TÜV SÜD?

TÜV SÜD is globally recognised for its quality and safety as a third party one-stop testing provider. We provide chemical testing services consistent with the requirements of ISO 10993 series, including 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.

Your benefits at a glance

Expert partnership: TÜV SÜD has extensive experience in all types of medical devices and regulatory requirements across markets.

Reduce time to global markets: With our in-depth insight of global product quality and regulatory requirements, TÜV SÜD optimises your costs and minimises time-to-market.

Single source testing solution: Together with our wealth of knowledge in complex regulations globally, TÜV SÜD provides a complete suite of testing solutions according to your needs.

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