🔍 Summary – Key Takeaways for Medical Device Manufacturers (2025)
- Understand what E&L testing for medical devices is and why it is crucial for patient safety and regulatory approval.
- Learn about the complete E&L testing process, including extractables and leachables study design.
- Discover new 2025 regulatory expectations from FDA, EMA, and ISO 10993-18 updates.
- Identify cost, timelines, and selection criteria for testing labs.
- Get insights into custom E&L testing solutions offered by ResolveMass Laboratories Inc.
- Find expert answers to top 10 FAQs in extractables and leachables testing for medical devices.
✅ Introduction: What is E&L Testing for Medical Devices and Why it Matters in 2025
E&L Testing for Medical Devices checks for harmful chemicals that may leach out during the use of a device. Extractables are substances that come out under stress, while leachables are those that actually move into the body under normal use conditions. In 2025, regulatory bodies now require more detailed chemical analysis, making E&L testing a crucial safety step.
Delaying E&L testing can cause setbacks in approvals and raise safety concerns. A good testing strategy supports every stage—from design to production to post-market monitoring. Planning early helps lower costs, avoid regulatory issues, and protect patients.
Explore our E&L Testing Services or see our E&L Testing Case Studies for success stories.
🧪 Understanding E&L Testing: Methods and Process
Extractables and Leachables (E&L) Testing is a two-phase analytical testing process:
| Aspect | Extractables | Leachables |
|---|---|---|
| Definition | Compounds that can be extracted from materials using aggressive solvents. | Compounds that migrate during actual product use. |
| Purpose | Worst-case analysis for potential chemical migration. | Realistic exposure assessment for patients. |
| Techniques Used | GC-MS, LC-MS, ICP-MS | Stability testing, analytical chemistry |
Learn more about our Extractables and Leachables Testing.
📘 Regulatory Guidelines for E&L Testing in 2025
Staying Compliant with Global Standards
Recent FDA guidance highlights the need for detailed toxicology data and strict detection limits. ISO 10993-18, along with its 2025 addendum, provides clearer rules on chemical testing and reporting. EMA guidelines now require that E&L data be included in broader risk assessments, especially for combination products.
Keeping up with these standards ensures faster approvals and fewer review delays. A well-prepared E&L report, including toxicity risk and detailed chemical results—can boost your chances of regulatory success.
Stay compliant with our E&L Testing & Patient Safety Strategy.
⚙️ When Do You Need E&L Testing for Medical Devices?
Common Scenarios That Require E&L Testing
E&L Testing for Medical Devices is needed for any product that comes into contact with the human body or bodily fluids. This includes:
- Implantable devices like stents or pacemakers
- Inhalers and nasal spray devices
- Catheters, tubing, and surgical instruments
- Disposable packaging and sterilized components
Even materials that seem safe—such as plastics or coatings—can leach harmful chemicals. Testing is also important when using new materials or changing suppliers. Having accurate data helps reduce the need for rework or resubmission.
ResolveMass offers tailored E&L Testing for Inhalation and Nasal Products.
E&L Testing for Medical Devices: Step-by-Step Workflow
- Material Review
This step involves reviewing all materials used in the device, including plastics, adhesives, inks, and coatings. It helps identify substances that might migrate during use. A complete list of materials and exposure conditions is essential for accurate testing. - Extractables Testing
Extractables testing uses high heat or strong solvents to force chemicals out of the device materials. It shows what substances could potentially leach under extreme conditions. This helps create a worst-case chemical profile for safety evaluation. - Leachables Testing
Leachables testing simulates real-life use, using conditions like body fluids or repeated sterilization. It reveals what chemicals actually migrate during normal use. This step is key for understanding real exposure risks to patients. - Chemical Analysis
Advanced tools like GC-MS, LC-MS, and ICP-MS are used to identify known and unknown compounds. These techniques detect very small amounts of chemicals. Accurate analysis supports risk assessment and regulatory reporting. - Toxicology Assessment
Detected chemicals are compared against safety limits to evaluate health risks. Toxicologists assess exposure levels, patient contact time, and toxicity data. This ensures that the device meets global safety standards.
These steps also help monitor changes over time, such as new material batches or manufacturing updates.
Explore Custom E&L Testing Solutions we offer for your specific device type.
💰 How Much Does E&L Testing for Medical Devices Cost?
Prices vary based on the number of materials, test methods needed, and depth of reporting. Early planning and scope definition can help control costs. Some labs offer customized or phased packages to match project needs and budget.
Find out more about the Cost of E&L Testing or use our E&L Cost Estimator.
🔬 Why Choose ResolveMass Laboratories for E&L Testing?
ResolveMass Laboratories is a leading expert in E&L Testing for Medical Devices. Their team includes skilled scientists, toxicologists, and chemists who understand global regulatory needs. They offer fast and accurate results while customizing test plans to each device’s use and materials.
From nasal sprays to implants, ResolveMass supports a wide range of products. Their services include full lifecycle support from development to post-market changes ensuring that your products stay compliant and safe.
Learn more about their comprehensive Extractable and Leachable EL Services.
Final Thoughts on E&L Testing for Medical Devices
In 2025, E&L Testing for Medical Devices is not just a compliance task—it’s a critical part of product safety and development. With stricter global standards, it’s more important than ever to invest in high-quality, reliable testing. Doing so helps avoid delays, supports strong submissions, and ensures that your medical device is safe for every patient.
If you’re ready to begin your E&L study, contact ResolveMass Laboratories today. Their expert team is ready to support your project from start to finish.
Ready to start your E&L study? Talk to our experts now via the Contact Page, or explore our extensive E&L Testing Service Offerings.
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Frequently Asked Questions (FAQs)
Extractables are chemicals that can come out of a medical device when it’s exposed to harsh conditions like heat or strong solvents. Leachables are the chemicals that actually move into the body during normal use, such as when the device contacts blood or tissue. Testing for extractables and leachables helps ensure that medical devices are safe for patients.
The FDA’s extractable and leachable guideline outlines how manufacturers should test medical devices for harmful chemicals. It recommends using scientific methods to detect and measure substances that may migrate from device materials into the body. The guideline helps ensure that all risks are properly assessed to protect patient health.
In 2025, global regulations have become stricter about chemical safety in medical devices. E&L testing is important because it helps identify harmful substances before the device reaches the patient. This testing is now a required step for product approvals.
Common testing methods include GC-MS for detecting gases, LC-MS for liquid compounds, and ICP-MS for metals. High-resolution mass spectrometry is also used to find unknown chemicals. These tools help create a full chemical profile of the device.
Yes, labs use non-targeted screening with advanced equipment to find unknown chemicals. Even if a substance was not expected, it can still be identified. This helps improve safety and meet regulatory requirements.
Reusable devices should be tested, especially if they are sterilized or cleaned multiple times. These processes can change the materials and cause new chemicals to leach. Testing ensures the device stays safe over time.
Devices that contact the body—such as implants, catheters, inhalers, or drug-delivery systems—require E&L testing. Even packaging and coatings may need to be checked. The goal is to make sure nothing harmful reaches the patient.
