Chemical characterisation is no longer a check box exercise. For today’s medical device developers, extractables and leachables (E&L) testing plays a critical role in risk mitigation, regulatory submission, and avoiding costly setbacks later in development. But for many small to mid-sized manufacturers, this stage is riddled with uncertainty. What testing do I really need?

The Eurofins Medical Device Services network of laboratories provides the clarity, speed, and scientific expertise you need to move forward with confidence. Our ISO 17025-accredited facilities, staffed by 100 dedicated E&L scientists, offer more than 30 years of experience and access to more than 500 advanced HPLC and GC systems. 

Important phases in your product development lifecycle that may require E&L assessments include:

• Developing new product design concepts 
• Performing verification testing for your design history file  
• Changing raw material suppliers 
• Implementing design or manufacturing process changes 

From protocol design to toxicological risk assessment, we support you every step of the way. We will work with you to:

• Determine the most appropriate test conditions for your device 
• Select the right solvents and extraction methods 
• Perform exhaustive or exaggerated extractables studies (ISO 10993-18) 
• Conduct simulated-use or leachables testing based on real-world exposure 
• Identify compounds using our proprietary spectral database of more than 1,500 non-volatile substances 
• Perform toxicological risk assessments (ISO 10993-17) with reports ready for regulatory submission 

Our coordinated E&L packages, often delivered in parallel with biocompatibility testing,  compress timelines and reduce the risk of late-stage issues. With direct access to our expert toxicologists, your project will benefit from real-time troubleshooting, guided decisions, and clear justifications for regulatory authorities.

• One unified workflow for E&L, toxicology, and biocompatibility 
• Dedicated project manager and expert point of contact 
• Risk assessments aligned with FDA guidance and ISO 10993 standards 
• Support during changes to raw materials, suppliers, or manufacturing processes 

Whether you're launching a new product, submitting a 510(k), or responding to a regulatory query, our goal is to help you uncover any potential issues before they become costly complications.

The responsive, reliable, and accessible teams within Eurofins Medical Device Services  ensure your E&L project stays on track, on time, and on budget. 

Instrumentation

• Agilent LC/MS TOF and QTOF 
• Agilent/Waters HPLC/UHPLC – including UV/Vis, RI, Fluorescence, ELSD, CAD, and Conductivity detectors 
• Agilent GC/MS – both headspace and direct injection sample introduction 
• Agilent GC/FID/TCD – both headspace and direct injection sample introduction 
• Agilent ICP/MS and ICP/OES 
• Thermo Scientific iCAP ICP-OES 
• Thermo Scientific LC/MS/MS 
• Perkin Elmer ICP-OES 
• Perkin Elmer 350 ATD Thermal Desorber 
• Bruker Avance 3 (500 MHz) Liquid NMR 
• Bruker Avance 3 (400 MHz) Liquid NMR 

Testing Available

Our extractables studies can be designed according to guidance such as ISO 10993 Part 18, USP <1663> and <1664>, as well as FDA/CDRH, EMEA and PQRI documents. 

• Validation in compliance with ISO 10993-18
• Extraction Techniques (for exaggerated, exhaustive, and simulated-use extraction) 
  • Reflux 
  • Soxhlet 
  • Sonication 
  • Incubation/maceration in controlled temperature conditions (with agitation if needed) 
• Analysis Techniques: 
  • Fingerprinting by GC-FID/MS 
  • Semi-quantitative screening for both volatile and semi-volatile organic compounds by GC/MS and GC/MS Headspace 
  • Semi-quantitative screening for non-volatile organic compounds by LC/MS 
  • Quantitative analysis for metals by ICP/OES or ICP/MS 
  • Gravimetric (NVR) determination of extractables 
  • FTIR 
  • TOC Analysis 
  • pH 
  • Conductivity 
• Method establishment for novel extraction matrices 
• Toxicological risk assessment 

Additional Complementary Services 

• Method Development & Validation 
• Stability for Leachables 
• Toxicological Risk Assessments 
• Biocompatibility Testing 
• Biological Evaluation Plans