Karin Nydahl
Laboratorieingenjör
Contact KarinIn the medical device manufacturing field, ensuring biocompatibility is crucial. Regulatory requirements are stringent and vary by market and device use, making compliance complex. Karin Nydahl, laboratory engineer at RISE, shares insights on regulatory requirements, practical approaches, and the future of biocompatibility testing.
"The regulatory landscape for biocompatibility testing in medical devices is stringent and varies depending on the market and the specific use of the device," Karin explains. In Europe, compliance with the Medical Device Regulation (MDR) and ISO 10993 standards is mandatory. These regulations ensure that medical devices are safe for patient use and do not cause adverse biological reactions.
Recently, there has been a significant shift towards substituting in vivo tests with in vitro tests. "This change aims to reduce the reliance on animal testing while still ensuring the safety and efficacy of medical devices," Karin adds.
In practice, the process of ensuring biocompatibility begins with identifying the necessary tests. At RISE, we focus on cytotoxicity tests and irritation tests. "Cytotoxicity tests are designed to check for cell toxicity, while irritation tests assess potential skin reactions," says Karin. These tests are performed using standardised methods and are accredited under ISO/IEC 17025 or according to Good Laboratory Practice (GLP), ensuring the quality and reliability of our studies.
"Throughout the testing process, we maintain open communication with our customers and stakeholders to address any concerns promptly," Karin notes. After completing the tests, we analyse the results to ensure they meet regulatory compliance standards, identifying any issues early. We compile detailed reports for regulatory submissions, ensuring thorough documentation. This structured approach ensures the medical device is biocompatible and ready for regulatory review, enhancing patient safety and product reliability.
Regulatory compliance in biocompatibility is complex—early planning and the right expertise are key to success.
Navigating complex regulatory requirements, such as those outlined in ISO 10993, can be overwhelming. Many companies, particularly start-ups and SMEs, lack the necessary in-house expertise and face the challenge of choosing from numerous service providers worldwide. To make an informed decision and select a test service provider that will best support your process, consider the following aspects:
"RISE aims to contribute to the further development of biocompatibility testing," Karin states. As part of the Technical Committee/Working Group of the ISO 10993 series, we are committed to evolving test methods. A significant focus has been on substituting in vivo tests with in vitro tests.
"Historically, RISE participated in the validation of in vitro skin irritation tests that are now part of the standard," Karin explains. Currently, we are focusing on sensitisation tests, with the long-term goal of offering in vitro tests that are included in the ISO standard. This ongoing effort ensures that biocompatibility testing continues to evolve, providing safer and more reliable medical devices.