✅ Summary: E&L Testing Checklist for Medical Devices (Free Download)
- Understand the critical importance of E&L testing in regulatory compliance and patient safety
- Learn how to implement a complete E&L testing checklist for medical devices
- Download a professionally curated checklist to streamline your testing workflow
- Navigate ISO 10993-18 and USP requirements efficiently
- Discover expert-backed services from ResolveMass Laboratories Inc., your CRO partner for E&L testing
- FAQs answered by specialists to meet FDA and EU MDR expectations
🔍 Introduction – E&L Testing Checklist for Medical Devices
E&L testing has become a necessary part of medical device development due to strict global regulations. Agencies like the FDA and EMA now expect manufacturers to follow clear, well-tested procedures to ensure devices are free from harmful chemical substances that could affect patient health. To support this need, ResolveMass Laboratories Inc. offers a free, easy-to-use E&L Testing Checklist for Medical Devices. This checklist is built on years of hands-on experience in both science and regulatory work. It’s designed to help teams avoid delays, stay compliant, and protect patient safety.
Our tool simplifies complex testing steps, making the process easier to manage without losing accuracy or quality. Whether you’re just starting development or preparing for final approval, this checklist can guide your team through each phase of the journey.
📘 What is E&L Testing?
Extractables and Leachables (E&L) testing looks for harmful chemicals that might be released from medical devices during use or over time. These substances can cause health problems if not identified and managed properly. Extractables are found under harsh lab conditions, while leachables are detected during regular device use.
| E&L Category | Definition | Purpose |
|---|---|---|
| Extractables | Compounds released under aggressive conditions | Identify potential risks |
| Leachables | Compounds released during normal use | Simulate real-world scenarios |
Testing is especially important for Class II and III medical devices, like implants or catheters, that contact the body directly or indirectly. A strong E&L Testing Checklist for Medical Devices helps ensure all chemical risks are fully evaluated.
👉 Explore our full-service E&L Testing Lab
✅ Why You Need an E&L Testing Checklist for Medical Devices
Following a proper checklist reduces mistakes, avoids delays, and builds trust with regulatory agencies. It also supports safety across the product’s lifecycle. Manufacturers who skip or overlook E&L steps often face audits, recalls, or even rejected submissions.
A structured E&L Testing Checklist for Medical Devices ensures every critical step like material review, risk assessment, and toxicological analysis—is addressed in the right order. It brings consistency to your testing process and makes it easier to document your work for compliance. In a fast-changing regulatory environment, having a reliable checklist is not just helpful, it’s essential for success.
At ResolveMass Laboratories, we’ve created a downloadable checklist designed for medical device developers at any stage—from concept to final approval.
📌 Components of a Robust E&L Testing Checklist for Medical Devices
Material Identification and Analysis
Start by listing all materials used in your device, such as plastics, adhesives, and coatings. Use tools like FTIR and TGA to understand the chemical structure of each material. This first step is critical to plan effective extraction studies later.
A full inventory helps spot potential chemical risks early and supports better decisions during test design.
➡ More on ISO-compliant E&L testing
Risk Assessment Strategy
Identify how and where the device touches the patient. Use ISO 14971 to measure risk levels based on time and type of contact. This helps decide what to test, when to test it, and what kind of toxicological review is needed.
A good risk assessment makes sure you test only what’s necessary—saving both time and money while keeping regulators satisfied.
Designing Extractables Studies
Choose the right solvents (like ethanol, water, or hexane) depending on your device’s materials. Use high temperature and long durations to pull out all possible chemicals. Follow USP <1663> for best practices.
Strong extractables testing shows how your device performs in extreme conditions, providing a safety buffer for patients.
Planning Leachables Studies
Next, simulate how your device is used in real life. Use standard testing conditions that match clinical environments. Monitor how the materials behave over time and look for any chemicals that might be released.
Leachables testing is essential for showing how safe your product is during actual use, not just in the lab.
Testing with Advanced Instruments
Use tools like GC-MS, LC-MS, and ICP-MS to detect and identify chemicals at very low levels. Every test should be validated to ensure it works reliably.
Modern instruments help find even the tiniest amounts of harmful substances, building trust with both regulators and healthcare providers.
Toxicology and Risk Evaluation
Compare chemical findings against safety limits, such as PDE and TTC values. Work with a qualified toxicologist to decide if any substance poses a health risk.
Toxicological reports explain why your product is safe, even if it contains trace chemicals. This step is vital for FDA and EU submissions.
➡ Custom Toxicological Studies
Documentation and Regulatory Readiness
Prepare full reports including test plans, raw data, validation results, and toxicological evaluations. Make sure your documents meet FDA, EMA, and ISO/GLP standards.
Good documentation proves that you’ve done everything by the book and helps avoid delays during regulatory review.
Why Choose ResolveMass Laboratories?
Expert Support Every Step of the Way
ResolveMass Laboratories brings years of experience in E&L testing for medical devices. Our lab is ISO/IEC 17025-accredited, and our services are tailored to meet your specific needs.
We support you from material analysis to regulatory submission. You’ll get transparent pricing, clear communication, and fast turnaround times. → See E&L testing costs
Whether you’re a startup or a global manufacturer, we help you navigate complex E&L requirements with confidence.
Explore our:
- E&L Testing and Patient Safety Program
- FAQs on E&L Testing
- Case Study: E&L Compliance in Real Devices
Free Download: E&L Testing Checklist for Medical Devices
Want to streamline your testing process? Download our E&L Testing Checklist for Medical Devices to make sure you’ve covered every important step. It’s been reviewed by experts and is regularly updated to reflect changing global regulations.
✅ Use it to:
- Improve testing efficiency
- Avoid missing critical steps
- Prepare better for regulatory audits
You can download the full E&L Testing Checklist here, or use the breakdown below to understand each section of this essential tool.
Related Services from ResolveMass
Additional Support for Medical Device Developers
We offer more than just E&L testing. Our other services include:
- Do I Need E&L Testing?
- Full E&L Study Workflow
- CRO Partnership Services
- Specialized E&L Testing for Implants
ResolveMass is your strategic partner in building safe and compliant products that reach the market faster.
📞 Ready to Start Your E&L Testing Project?
Top FAQs: E&L Testing Checklist for Medical Devices
The checklist helps ensure that every step in the E&L testing process is covered—starting from material selection to final toxicological evaluation. It acts as a roadmap for manufacturers to avoid missing important testing phases. This ultimately reduces delays, improves safety, and increases the chances of regulatory approval.
E&L testing is required for Class II and III medical devices, especially those that come in contact with the human body—either directly or indirectly. This includes devices like implants, catheters, and drug delivery systems. Regulatory bodies require this testing to ensure patient safety and chemical compatibility.
The choice of solvents depends on the materials used in the device and should be selected based on their polarity and extraction potential. Following guidelines like USP <1663> helps in choosing appropriate solvents to ensure all potential extractables are identified. This supports a more accurate safety evaluation.
E&L testing should be revisited whenever there are significant changes in materials, manufacturing processes, or regulatory requirements. Even if your device passed previous testing, any update that may affect chemical interactions should trigger a re-evaluation to maintain compliance and safety assurance.
Leachable thresholds are usually based on Permitted Daily Exposure (PDE) values or Thresholds of Toxicological Concern (TTC). These benchmarks help determine if the amount of a detected substance is within safe limits for patients. Regulatory bodies use these thresholds to assess risk and ensure safety.
No, toxicological evaluation is a required step, regardless of the amount detected. Even small quantities of certain chemicals can pose health risks, especially with long-term exposure. A certified toxicologist must assess the findings to determine whether they are within acceptable safety limits.
ISO 10993-18 provides the framework for chemical characterization but needs to be used alongside other standards like USP <1663> and <1664>. Real-use simulations, analytical validations, and toxicological assessments are also essential to meet full regulatory expectations for E&L testing.
