🔍 Summary: Key Takeaways
- E&L Regulatory Requirements for Medical Devices vary significantly across the US (FDA), EU (MDR), and Canada (Health Canada).
- The US FDA emphasizes biocompatibility and ISO 10993-18-based assessments.
- The EU MDR focuses on risk-based evaluations aligned with ISO 10993, plus unique vigilance and PMS (Post-Market Surveillance) requirements.
- Canada aligns closely with ISO 10993-18 and requires detailed toxicological risk assessments.
- Manufacturers must partner with reliable CROs like ResolveMass Laboratories Inc. to meet cross-border compliance.
- This guide provides a side-by-side comparison table, top FAQs, and essential compliance resources.
- It focuses on how to successfully address E&L regulatory requirements for medical devices globally.
✅ Introduction
Understanding and meeting E&L Regulatory Requirements for Medical Devices is essential for companies aiming to enter international markets. The United States, European Union, and Canada each have their own unique expectations, all of which require scientifically sound, ISO 10993-18-aligned extractables and leachables (E&L) testing. For medical device manufacturers, knowing and addressing these differences is crucial—not just for compliance, but for smooth and timely product approvals.
At ResolveMass Laboratories Inc., we bring together years of scientific knowledge and regulatory insight to help you meet these global requirements. Our E&L testing programs are tailored to meet both international standards and local guidelines. This article explores and compares E&L expectations across key regions, using a practical approach that aligns with E-E-A-T best practices and is fully optimized for search engine visibility.
Why E&L Testing is Critical for Global Device Approval
E&L testing identifies chemicals that may come out of medical devices during use. These substances can originate from device materials, coatings, packaging, or even during the manufacturing process. If not properly assessed, they may pose health risks to patients.
Regulatory agencies across the globe require evidence that a medical device is chemically safe. Testing extractables and leachables helps manufacturers understand risks and protect end-users. It also supports regulatory submissions by providing scientific data that meets each region’s specific standards.
An effective E&L strategy ensures product safety, speeds up approvals, and supports post-market surveillance—all of which are essential for market success.
For a deeper understanding, explore:
➡️ Extractables and Leachables (E&L) Services
➡️ Do I Need E&L Testing for My Medical Device?
Understanding E&L Regulatory Requirements for Medical Devices by Region
| Region | Regulatory Body | Main Standards | Key Requirements |
|---|---|---|---|
| USA | FDA | ISO 10993-18, FDA Guidance | Biocompatibility, chemical risk, patient-specific data |
| EU | European Commission | MDR 2017/745, ISO Standards | Chemical safety, vigilance, and post-market tracking |
| Canada | Health Canada | ISO 10993-18, GD210 | Strong analytical data and toxicology justification |
Manufacturers should base their testing on ISO 10993-18, but also adapt to local expectations. While the core testing principles are similar, documentation and risk assessments need to be tailored for each region.
Learn more about ISO 10993-18 compliance at
➡️ ISO 10993-18 E&L Testing Explained
U.S. Focus: FDA’s Approach to E&L Testing
The U.S. Food and Drug Administration (FDA) expects clear chemical data when evaluating moderate- and high-risk devices (Class II and III). E&L testing falls under ISO 10993-18 guidelines and supports the overall biocompatibility review process.
Manufacturers must provide detailed chemical profiles, supported by analytical tools like GC-MS, LC-MS, and ICP-MS. Along with this, toxicological risk assessments (TRA) are required to determine whether identified substances could harm patients under normal use.
The FDA also expects proper justification for materials used in the device and documentation explaining the testing choices made by the manufacturer.
✅ More info:
➡️ Analytical Techniques for E&L Testing
➡️ Custom E&L Testing Programs
EU Regulations: How MDR Shapes E&L Requirements
The European Union’s MDR (Medical Device Regulation 2017/745) requires that manufacturers not only follow ISO 10993-18 but also link their E&L results with broader safety and performance requirements.
EU regulators place strong emphasis on risk management and post-market activities. This means that E&L data should be updated as part of routine monitoring and included in clinical evaluation reports. Manufacturers must plan early and ensure that chemical safety is well-documented throughout the product lifecycle.
In Europe, chemical characterization and toxicology must be integrated into both pre-market and post-market processes to comply with MDR.
EU-MDR requires significant documentation. Explore:
➡️ E&L Testing Checklist
Canadian Perspective: Health Canada’s E&L Testing Framework
Health Canada follows ISO 10993-18 as well, but adds extra layers of documentation and analytical rigor. The GD210 guidance specifies how extractables and leachables must be identified, and how manufacturers should validate their testing methods.
E&L data submitted to Health Canada must be detailed, with scientific references and validated toxicological risk assessments. In addition to pre-market testing, Canadian authorities expect traceable documentation that explains every analytical decision made.
Manufacturers must maintain transparency in methodology, material selection, and risk analysis to satisfy Canadian requirements.
Stay compliant with:
➡️ E&L FAQs
➡️ Cost of E&L Testing
Building a Strong E&L Regulatory Strategy for Medical Devices
A well-planned approach to E&L testing can make the difference between approval and rejection. Manufacturers should:
- Start early in development to build testing into timelines.
- Use ISO 10993-18 as a foundation, then adjust per region.
- Work with expert CROs, like ResolveMass Laboratories, who understand international regulatory frameworks.
- Maintain thorough documentation, including test plans, validation reports, and TRA findings.
Proper alignment with E&L Regulatory Requirements for Medical Devices ensures safety, speeds up review times, and builds trust with global authorities.
For hands-on support:
➡️ CRO for Medical Device Testing
Case Example – Navigating E&L Requirements Across Borders
ResolveMass Laboratories Inc. recently supported a high-risk implant through approval in the U.S., EU, and Canada. Each submission required a unique set of E&L data tailored to that region’s needs.
Working closely with toxicologists and regulatory consultants, the ResolveMass team prepared ISO 10993-18-compliant reports with region-specific addenda. The result was smooth, first-pass approvals in all three markets—saving both time and cost.
This example highlights the value of strategic planning and regulatory expertise in managing E&L Regulatory Requirements for Medical Devices globally.
Read the full story:
➡️ E&L Compliance Case Study
Conclusion: Meeting E&L Regulatory Requirements for Medical Devices the Right Way
Meeting E&L Regulatory Requirements for Medical Devices is not just about passing tests—it’s about proving that your device is safe for the people who use it. Whether you’re targeting the U.S., EU, or Canadian market, the key to success lies in early planning, expert guidance, and complete documentation.
ResolveMass Laboratories Inc. helps manufacturers streamline the E&L process, from chemical analysis to toxicological reporting, ensuring that every requirement is covered. With a partner who understands the global landscape, you can accelerate product approvals and build long-term trust in your devices.
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FAQs on E&L Regulatory Requirements for Medical Devices
The FDA places strong emphasis on chemical characterization and toxicological risk, with detailed guidance on study expectations. The EU MDR, while also referencing ISO 10993-18, integrates E&L data into broader risk management and post-market monitoring frameworks.
Yes, a single report based on ISO 10993-18 can serve as the core for multi-region submissions. However, each region may require specific additions or justifications, so minor modifications are often needed to meet local guidelines.
The timeline for E&L testing can range from 4 to 18 weeks, depending on the complexity of the device and the regulatory needs. Planning early in the development process helps avoid delays and ensures smoother submissions.
TRA helps evaluate whether the detected leachables pose any health risk to the patient based on exposure levels and toxicological data. This step is crucial for regulatory approval and must be supported by qualified toxicologists.
Absolutely. Complete and clear documentation—including test protocols, validation data, and justification for all decisions—is critical. Regulatory agencies review this closely to assess the safety and compliance of the device.
