Genotoxicity testing for medical devices

Conducting genotoxicity assessment and evaluation for medical devices can help manufacturers understand and mitigate potential adverse effects when the device heads to market.

Although biocompatibility testing of medical devices has largely been conducted in terms of sensitization, irritation, and system toxicity, there are growing concerns that medical devices can also contribute to changes in the DNA structure, exerting genotoxic effects. Now, in vitro genotoxicity assays must be conducted on devices that are intended for permanent implantation or prolonged bodily exposure to identify the potential presence of toxins that could have an effect on the genetic material of cells.

Genotoxicity tests are designed to detect substances that could cause genetic damage via either gene mutations or chromosomal damage and must adhere to the International Organization for Standardization’s “Tests of Genotoxicity, Carcinogenicity, and Reproductive Toxicity” as outlined in ISO 10993-3.

Any medical device hoping to head to market must undergo biocompatibility testing to protect humans from potential biological risks and complications stemming from using medical devices. This process establishes the device’s biological safety and ensures that the device can perform its job in various environments. TÜV SÜD’s laboratories perform a variety of in vitro test methods to ensure that the end product is not going to cause harm in any way, including genotoxicity testing and evaluation.

The ISO 10993 standard requires a structured biological evaluation plan within a risk management process. TÜV SÜD can assist with the biological evaluation plan generation, toxicological risk assessment, and the conclusive biological evaluation report to help your device meet the risk requirements of the standard.

TÜV SÜD provides a comprehensive range of medical device testing solutions required by relevant regulatory frameworks worldwide. Our expert team offers a comprehensive biocompatibility testing panel for medical devices, including genotoxicity assessment, all conducted in our state-of-the-art laboratories located across the globe.

By helping to address medical manufacturers’ needs in determining and understanding the chemical characterization process and testing outcomes, TÜV SÜD acts as an instrumental partner in ensuring regulatory compliance for organizations of all sizes. We provide end-to-end assistance with efficient use of resources while ensuring that project timelines are met with predictability and diligence.

TÜV SÜD offers complete biocompatibility testing solutions for medical devices through our state-of-the-art laboratories and expert team of medical doctors, engineers, and toxicologists located across the globe.

• Genotoxicity – ISO 10993-3 & FDA: Genotoxicity tests are required to identify the presence of toxins that can impact the genetic material of cells. Since no single test can detect all genotoxins, we recommend the following two in vitro tests:
• Bacterial Reverse Mutation Assay. This test is conducted with engineered strains of Salmonella typhimurium and Escherichia coli designed to detect single base pair changes and frameshift mutations (OECD 471, 1997).
• In Vitro Mammalian Genotoxicity Assay. A choice of one of the following is recommended:

1. Mouse Lymphoma Gene Mutation Assay (OECD 476, 1997), which is preferred as it detects the broadest range of genotoxic mechanisms associated with carcinogenic activity.
2. In Vitro Chromosomal Aberration (CA) Assay (OECD 473, 2014), providing information on DNA damage through structural chromosomal changes.
3. In Vitro Micronucleus Assay (OECD 487, 2014). This test evaluates the presence of micronuclei resulting from DNA damage and provides information on clastogenicity and aneugenicity.

TÜV SÜD is globally recognized and trusted for its quality and safety as a third-party one-stop testing provider. We offer a suite of testing services required for medical devices and help manufacturers and suppliers meet global regulatory standards independently.

• Globally recognized medical device expertise – TÜV SÜD is a trusted partner with dedicated teams of global experts committed to helping your organization manage risks and bring the safest medical devices to market. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD Product Service is recognized by regulatory authorities worldwide for its extensive experience with all types of medical devices.
• Risk management expertise – TÜV SÜD experts have extensive experience across all aspects of risk management systems for medical device manufacturers in accordance with ISO 10993-3 and ISO 14971, conducting thousands of in-depth risk management audits each year. TÜV SÜD laboratories are fully ISO 17025 accredited, and US laboratories also perform testing under Good Laboratory Practice (GLP).
• Active involvement in standards development and implementation – TÜV SÜD takes a proactive approach to anticipating technological developments and facilitating change. Our experts participate in standard-setting committees and consortiums to help define future standards in safety, security, and sustainability, going beyond regulatory compliance to inspire trust in a physical and digital world.
• Single source solution – TÜV SÜD offers testing services for major medical device markets in accordance with international standards and regulations.
• Other testing and certification services – In addition to biocompatibility assessments required for medical devices, TÜV SÜD Product Service also provides compliance testing in accordance with other relevant regulations and standards.