Pyrogenicity refers to a substance’s ability to induce a febrile (fever) response – it can be either microbial-mediated or material-mediated. In the context of medical devices, pyrogenic responses arise from different sources and therefore require distinct testing methods for detection. Uncertainty about which pyrogenicity test is most suitable is therefore an obstacle that many manufacturers face, creating frustration and stalling timelines. Not to mention the cost implications of repeating complex assays. But identifying and mitigating the risk of pyrogenic reactions is non-negotiable. Whether microbial or material in origin, pyrogens must be assessed with clarity, precision, and confidence.

Eurofins Medical Device Services network of laboratories provides full-service pyrogenicity testing services to support biological safety evaluations across all stages of device development. Our experts advise on the appropriate testing route based on your product, to remove uncertainty from your regulatory strategy.

Services:

• Bacterial Endotoxin Test (BET), we offer the choice of endotoxin testing using the traditional LAL(Limulus Amebocyte Lysate), or Recombinant Factor C (rFC) Assay, a synthetic, sustainable, and highly specific method for endotoxin detection, that is recognised in global pharmacopeias (Ph. Eur. 2.6.32, USP <86>, JP <4.01>) and is aligned with the latest USP updates effective May 2025. Unlike the traditional LAL test, rFC does not require horseshoe crab blood—eliminating the ethical and environmental concerns surrounding this resource-intensive practice. 
• Monocyte Activation Test (MAT), an advanced in vitro method that measures the release of cytokines from blood to detect both endotoxin and non-endotoxin pyrogens.
• Whole Blood Pyrogen Test, also uses blood and cytokine release, replicating the natural immune response to ensure a realistic assessment.

Assessments are conducted per ISO 10993 guidance and regulatory requirements across international markets. This includes evaluation of material-mediated pyrogens. ISO 10993-11, Annex G provides examples of substances known to generate a pyrogenic response without being endotoxins.

Staying ahead of evolving standards is crucial. Eurofins Medical Device Services adapts to emerging methodologies while ensuring compliance and accelerating time to market.