The requirements for assessing irritation for medical devices has moved from ISO 10993-10 to ISO 10993-23 and with this new standard comes the inclusion of in vitro irritation testing as a recognized method. This is a critical turning point as we move further to incorporate the 3 R’s (replace, reduce, refine) into the biocompatibility assessment for medical devices. This new route of evaluation nevertheless creates new challenges which can be summarized in three critical points: regulatory acceptance, ability to find a CRO with a validated in vitro procedure for medical devices, and incorporation of the in vitro method into the biocompatibility approach for manufacturers.
Regulatory agencies around the world are working to incorporate the method into national standards and define how and when it can be used in the biological safety assessment of medical devices. This is expected to be complete for most countries within the next year. Nelson Labs has offered this method as a materials screening option for a few years now to allow manufacturers to gather in vitro data on approved devices and is now ready to propose this testing under GLP conditions per ISO 10993-23. In upcoming submissions, and until each regulatory agency has taken a final position on the in vitro alternative, manufacturers should contact the competent authorities to evaluate their acceptance of the method.
