Navigating biocompatibility regulations in medtech

Understanding regulatory requirements for biocompatibility

"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.

Practical approaches to meet biocompatibility requirements

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.

Choosing the right service provider – key factors to consider

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:

• Expertise and experience: Does the provider have experience in testing medical devices similar to yours?
• Accreditation and certification: Is the provider accredited and certified by recognised bodies, and do they comply with international testing standards such as GLP?
• Track record: What is the provider’s track record for delivering accurate, reliable, and timely results? Ask for references to verify their credibility.
• Communication: Can you easily reach the provider throughout the testing process? Will they be responsive and supportive?
• Customisation and flexibility: Does the provider offer customised and flexible services? Can they tailor their services to meet your specific needs and accommodate changes or additional requests?

How RISE contributes to the future of biocompatibility testing

"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.