Key Takeaways
✔ Extractables and Leachables (E&L) testing is vital for patient safety, regulatory compliance, and product approval.
✔ Class II and Class III medical devices require E&L testing; Class I devices may also benefit depending on use.
✔ Devices with plastic, rubber, or coated components that contact the body or body fluids typically require testing.
✔ The process uncovers potentially harmful chemicals that may migrate from materials into patients.
✔ Collaborating with an experienced CRO like ResolveMass supports robust method development and smooth regulatory submission.
✔ Speak with a CRO scientist to determine if your specific device requires E&L testing.
✔ Get detailed insights on timelines, testing strategies, and cost options from experts.
Introduction: Is E&L Testing Necessary for Your Medical Device?
When getting ready to bring a medical device to market, an important question to ask is: Do I need E&L testing for my medical device? The answer depends on how the device interacts with the human body—but in many cases, E&L testing is a must.
Devices that come into contact with blood, tissues, or body fluids—whether directly or indirectly—need to be carefully checked for safety. Extractables and leachables (E&L) testing is a key part of this evaluation. Regulatory agencies such as the FDA, EMA, and Health Canada usually require detailed E&L data in your submission. Working with a Contract Research Organization (CRO) like ResolveMass Laboratories Inc. can make the process easier. Their knowledge and testing capabilities help speed up approvals and remove uncertainty.
What Is E&L Testing and Why Is It Important?
E&L testing involves identifying chemicals that can migrate from your device materials into a patient’s body. This includes both extractables, which are compounds that come out under extreme conditions, and leachables, which appear under normal usage.
Even small amounts of these chemicals can cause allergic reactions or toxic effects. That’s why E&L testing is essential for proving that your device is safe for real-world use. Testing also helps avoid problems with regulatory agencies like the FDA, EMA, or Health Canada.
Do I Need E&L Testing for My Medical Device? Understanding the Risks
To determine “Do I need E&L testing for my medical device?”, consider the following:
- Does your device come in contact with blood, tissue, or body fluids?
- Is it made from plastic, rubber, coatings, or adhesives?
- Does it deliver drugs or fluids internally?
- Is it classified as a Class II or Class III device?
If you answered yes to any of these, then E&L testing is likely needed. Even some Class I devices may require testing depending on how they are used. A conversation with a CRO scientist can help clarify your device’s exact needs.
Which Medical Devices Require E&L Testing?
| Device Type | Is E&L Testing Needed? | Reason |
|---|---|---|
| Surgical implants (Class III) | ✅ Yes | Long-term body contact |
| Catheters, stents (Class II/III) | ✅ Yes | Blood or tissue exposure |
| Drug-device combinations | ✅ Yes | Dual regulation (drug + device) |
| IV sets, syringes, tubing | ✅ Yes | Internal fluid pathways |
| Bandages, skin patches | ⚠️ Maybe | Based on material and duration |
| In vitro diagnostics | ❌ Rarely | No direct body contact |
In general, if your device touches the body and includes synthetic materials, it’s safer to assume E&L testing is required.
🔗 E&L Testing for Medical Devices
What Happens During the E&L Testing Process?
E&L testing follows a structured process to ensure nothing is missed:
Material Review
All device components are reviewed to understand their chemical makeup and possible risks. This step includes collecting detailed information about polymers, coatings, adhesives, and additives used. Understanding the source and nature of each material helps predict which chemicals may be released during use.
Extraction Method Design
Custom testing plans are built to reflect how your device will be used, including both regular and worst-case scenarios. Conditions such as temperature, time, and solvent type are tailored to simulate real-life and extreme exposures. Following ISO 10993-12 guidelines ensures the testing method is scientifically sound and regulatory-compliant.
Lab Analysis
High-tech instruments like GC-MS, LC-MS, and ICP-MS are used to detect even tiny traces of harmful substances. These tools provide highly sensitive and specific measurements, ensuring no critical compound is missed. Multiple techniques are often combined to get a full chemical profile of the extractables and leachables.
Toxicology Assessment
Expert toxicologists review the results to confirm that all detected substances are within safe levels. Each compound is assessed against established safety thresholds based on exposure duration and patient risk. The goal is to ensure no chemical present in the device poses harm during normal use.
Final Report Preparation
The findings are compiled into a complete, submission-ready report for regulatory agencies. Reports include full test methods, raw data, toxicological evaluations, and justification of safety margins. This documentation is structured to meet the expectations of agencies like the FDA, EMA, and Health Canada.
This process makes sure your device is safe, well-documented, and ready for approval.
More on Custom E&L Testing
Why Work with ResolveMass for E&L Testing?
ResolveMass Laboratories offers over 15 years of experience in E&L testing. Our CRO team understands both the science and the regulations. Here’s why clients choose us:
- Fully GLP-compliant labs with the latest equipment
- Deep knowledge of FDA, EMA, ISO, and Health Canada standards
- Flexible testing plans for any budget or device size – E&L Testing Solutions
- Fast turnaround to meet your launch timelines
- A focus on patient safety from start to finish – Patient-Centric Testing
Working with a skilled CRO like ResolveMass reduces guesswork and helps your product succeed.
Avoid These Common Mistakes in E&L Testing
It’s easy to run into trouble if you don’t plan properly. Here are a few common pitfalls:
❌ Thinking short-term contact doesn’t need testing
❌ Using generic materials without checking them
❌ Sending incomplete data to regulators
❌ Skipping early consultation with E&L experts
Starting early and working with a CRO prevents delays and costly do-overs later. CRO experts
How Much Does E&L Testing Cost?
The cost of E&L testing depends on:
- Number of materials in your device
- The chemical complexity of those materials
- Type and depth of testing needed
- Any toxicology or custom reporting included
At ResolveMass, we offer tailored quotes based on your exact device. Investing in E&L testing early saves time and prevents future issues like product recalls or redesigns.
Check our pricing guide:
🔗 Cost of Extractables & Leachables Testing
Final Answer: Do I Need E&L Testing for My Medical Device?
In most cases, yes. If your device touches the human body or involves drug delivery, E&L testing is not just recommended—it’s essential. It protects patients, ensures compliance, and helps you avoid delays.
Still wondering, “Do I need E&L testing for my medical device?” Speak to a CRO expert at ResolveMass. We’ll guide you through the next steps, develop a testing plan, and make sure your product is ready for approval.
Find more in our FAQ:
🔗 E&L Testing FAQs
Ready to Start E&L Testing?
✅ Here’s how ResolveMass can help:
- Explore our E&L testing services
- Contact a CRO scientist for a free consultation
- Request a detailed quote
- Access our E&L testing guide for different device types
Don’t let uncertainty slow down your project. Take control today with expert support from ResolveMass Laboratories.
📌 Contact Us
FAQs – Do I Need E&L Testing for My Medical Device?
Not every device needs E&L testing, but many do—especially Class II and Class III devices. If your device touches blood, tissue, or body fluids, testing is usually necessary. Some Class I devices may also require testing based on how and where they are used.
E&L testing typically takes between 4 to 14 weeks, depending on the device’s complexity and the number of materials involved. Custom testing plans or extra toxicology assessments may extend the timeline slightly. Early planning helps avoid delays.
Testing follows globally recognized standards like ISO 10993-18 and USP <1663>/<1664>. These guidelines ensure the testing process is thorough, accurate, and acceptable to regulatory agencies like the FDA, EMA, and Health Canada.
Yes, once chemical compounds are identified, toxicologists evaluate them to see if they pose any health risks. This review helps determine whether the amounts found are within safe exposure limits for patients during typical use.
Sometimes. If your device design and materials haven’t changed, the same data may be reused for future submissions. However, different countries or updated guidelines may require additional testing or documentation.
Common tools include GC-MS (Gas Chromatography-Mass Spectrometry), LC-MS, ICP-MS, and UV-VIS. These instruments detect even very low levels of extractable or leachable substances, helping ensure no harmful chemicals are overlooked.
Custom testing reflects how your device will be used in real life. It ensures that testing conditions match your product’s application, helping avoid over- or under-testing. This leads to better results and faster regulatory approvals.
Skipping E&L testing can lead to regulatory rejection, market delays, or costly product recalls. Most importantly, it puts patient safety at risk. It’s better to address potential chemical risks before they become serious problems.
