Irritation is one of the three most common tests used to assess a medical device’s potential to cause an immediate reaction following exposure to the body. Yet many manufacturers face costly delays, compliance issues, or even test failures simply because they weren’t sure how or when to approach irritation testing—or which method to use. With constantly evolving regulations, complex material interactions, and the need to ensure patient safety across multiple exposure routes, choosing the right testing partner can make all the difference.

At the Eurofins Medical Device Services network of laboratories, we specialise in guiding manufacturers through irritation testing with clarity, accuracy, and confidence. Whether you’re facing skin, mucosal, or ocular exposure pathways, our experienced scientists will help you navigate ISO 10993-23 and USP <88> requirements to ensure your device’s safety and regulatory compliance.

We offer a comprehensive portfolio of irritation testing solutions across all key exposure routes. Our test selection is tailored to your device’s contact type and route of administration. Whether you're testing for acute irritation potential or preparing data for a regulatory submission, we’ll recommend the most scientifically and ethically appropriate method—be it in vivo or a validated human-relevant in vitro model such as Reconstructed Human Epidermis (RhE) or full-thickness skin equivalents.

The Eurofins Medical Device Services network of laboratories provides early-stage consultation to define sample requirementsand optimal test design, conducts comparative analysis to guide the choice between in vivo and in vitro assays, supports strategic planning to minimise rework and speed up approvals, and offers expert interpretation of results and their clinical significance.

Regulatory

• ISO 10993-23:2021 Biological evaluation of medical devices Part 23: "Tests for irritation" provides the general requirements for evaluating irritation potential of a medical device.
• ISO 10993-1 Table A.1 – "Endpoints to be addressed in a biological risk assessment”