Navigating the path to regulatory approval is complex—particularly when it comes to biocompatibility testing. If you’re working on a novel device or optimising an established product, the potential for costly delays, missteps in test selection, or late-stage failures looms large. For small and medium-sized manufacturers, knowing when and how to engage an external laboratory can be unclear. Larger organisations, meanwhile, often begin testing too late—putting development timelines and market introduction at risk.

Eurofins Medical Device Services network of laboratories has a global team of highly qualified toxicologists in biological safety testing, delivering clarity, speed, and regulatory alignment at every stage of the device lifecycle. Sensitisation is one of the three most common endpoints required to ensure the safety of a medical device. It evaluates the risk of a material or product causing an allergic response after repeated exposure. This is a critical component of ISO 10993-10:2021 compliance and a mandatory checkpoint for market approval. We offer both in vivo and in vitro assays tailored to the specific exposure routes of your device. Testing is conducted via our trusted partner laboratories in the EU and US.

We don’t just conduct tests, we guide you to the right ones. Our toxicologists interpret ISO 10993-10 and ISO 10993-1 to ensure your test strategy aligns with regulatory expectations and is suitable for your device type and intended use. Eurofins Medical Device Services network of laboratories will support required testing and determine when to begin, select the best method(s) (to avoid unnecessary repeat testing) for your device, minimise sample waste and resource burden, and identify and mitigate the risk of sensitisation-related delays. It’s comprehensive support at every stage.

Regulatory

• ISO 10993-10:2021 "Biological evaluation of medical devices Part 10: Tests for skin sensitisation" provides the general requirements for evaluating the sensitising potential of a medical device."
• ISO 10993-1 Table A.1 – "Endpoints to be addressed in a biological risk assessment”