When medical devices fail, the consequences can be serious – for patient safety, for your team, and for your product’s future. In many cases, degradation from exposure to cleaning agents, sterilisation processes, body fluids, or reagents can compromise device performance. But understanding these risks isn’t always straightforward. Regulatory requirements vary, and without clear guidance or access to dedicated chemical testing, the likelihood of costly delays and expensive retesting increases.

The Eurofins Medical Device Servicesnetwork of laboratories provides chemical compatibility testing services designed to protect the functional integrity of your device and prevent late-stage regulatory or clinical issues. Our comprehensive programme assesses how your chosen materials or assembled products interact with the chemicals they are likely to come into contact with during manufacture, use, reprocessing, or sterilisation. 

Whether you are testing polymers, coatings, or composite materials, we offer a structured, risk-based approach to compatibility studies with: 

• Breakdown of product materials and use-case analysis 
  Identification and categorisation of potential chemical exposures 
  Protocol development aligned with your device’s regulatory pathway 
  Exposure testing using real-world disinfectants, solvents, or fluids 
  Assessment techniques including Fourier Transform Infrared Spectroscopy (FTIR), Scanning Electron Microscopy (SEM), optical clarity, and mechanical analysis 

Our scientists work partner with your team to define appropriate test conditions and simulate realistic use environments. We assess changes in material properties such as discolouration, brittleness, or mechanical failure, and highlight the implications these may have on safety and performance.

If a failure does occur, our team will conduct root cause analysis and provide actionable guidance for remediation with reports including recommendations on sustainable material selection. This will reduce rework and mitigate unnecessary delays in the approval process.

With access to an extensive catalogue of disinfectants, and deep experience across device classes and regulatory frameworks, the Eurofins Medical Device Services network of laboratories delivers detailed, data-driven reports you can submit with confidence.