1. Why Extractables and Leachables Testing Matters

Every medical device interacts with patients, tissues, fluids or drugs. Materials such as plastics, polymers, elastomers, coatings, adhesives and metals may release chemicals under certain conditions.

E&L failures can result in:

• Regulatory delays
• Product recalls
• Patient safety concerns
• Failed EU MDR or USFDA submissions
• Additional retesting and increased cost
• Loss of market trust

Even a trace level of a harmful chemical impurity can create significant clinical and regulatory issues.

This is why global regulatory bodies now emphasize chemical safety as a core part of biological evaluation. Manufacturers must show clear evidence that their devices do not release harmful substances.

2. Difference Between Extractables and Leachables

Understanding the distinction is crucial for compliance.

Extractables

Extractables are chemicals that can be pulled out of the device material under aggressive laboratory conditions. These tests help identify potential chemical hazards that might appear under extreme situations.

Leachables

Leachables are chemicals that actually migrate into the body or solution under normal use conditions. These results represent the real exposure risk for patients.

Both extractables and leachables need to be assessed to build a complete chemical safety profile.

3. Regulatory Requirements: ISO 10993-17 and ISO 10993-18

Global regulators require manufacturers to follow:

ISO 10993-18 – Chemical Characterization

This includes:

• Material composition analysis
• Extractables study
• Leachables study
• Identification of unknown chemicals
• Quantification of detected substances
• Assessment of potential chemical interactions

It helps create a complete chemical profile of the medical device.

ISO 10993-17 – Toxicological Risk Assessment

This involves:

• Determining patient exposure doses
• Assessing potential health risks
• Comparing exposure with safe limits
• Identifying chemicals of concern
• Establishing Margin of Safety

TRA ensures that the detected chemicals do not harm the patient.

4. What Accuprec Offers in E&L and TRA Testing

Accuprec provides end-to-end E&L and TRA services under ISO 10993-17/18 using advanced analytical platforms and expert toxicological evaluation.

A. Chemical Extraction Studies

Accuprec performs extraction under various conditions:

• Aqueous solvents
• Organic solvents
• Simulated use conditions
• Accelerated extraction

This helps detect a wide range of potential chemical risks.

B. Analytical Testing

Using advanced instrumentation such as:

• GC-MS
• LC-MS/MS
• ICP-MS
• FTIR
• UV-Vis
• Headspace GC

Accuprec identifies and quantifies:

• Volatile organic compounds
• Semi-volatile compounds
• Non-volatile compounds
• Metals
• Plasticizers
• Additives
• Residual solvents
• Processing impurities

C. Leachables Studies

Accuprec evaluates leachables under:

• Real-use conditions
• Simulated clinical conditions
• Accelerated exposure

This provides realistic exposure levels for toxicological evaluation.

D. Toxicological Risk Assessment (TRA)

Accuprec’s toxicologists perform detailed TRA that includes:

• Identification of chemical hazards
• Evaluation of exposure levels
• Comparison with safe toxicological thresholds
• Margin of Safety (MoS) calculation
• Residual risk estimation
• Toxicological summary for global regulators

TRA reports prepared by Accuprec meet international standards and are accepted under EU MDR and USFDA submissions.

E. Regulator-Ready Documentation

Accuprec prepares:

• E&L summary reports
• Toxicological Risk Assessment reports
• ISO 10993-17/18 compliant documentation
• Data integration for Biological Evaluation Report (BER)
• Justification for biological safety

This ensures strong support for global regulatory submissions.

5. Why E&L and TRA Are Critical for EU MDR and USFDA Approvals

Regulatory bodies expect clear evidence that the device is chemically safe. Incomplete E&L or TRA is one of the top reasons for rejection.

EU MDR specifically requires:

• Comprehensive material characterization
• Chemical identification
• Toxicity justification
• Detailed risk evaluation
• Explanation of risk acceptability

USFDA expects:

• Detailed extractables profile
• Leachables under clinical use
• Toxicological thresholds
• Margin of Safety calculations
• Justification for skipped tests

Accuprec’s E&L and TRA services meet all these expectations.

6. How Accuprec Helps Manufacturers Reduce Regulatory Risks

a. Early Chemical Risk Identification
Detecting risks early helps adjust materials or processes before submission.

b. Strong Toxicological Justification
Accuprec’s toxicologists evaluate each chemical thoroughly, ensuring robust justification.

c. Avoiding Rejections
Clear analytical reports and strong TRA prevent queries, retests or delays.

d. Faster Global Approvals
Accurate data and scientific clarity shorten evaluation time for regulators.

e. Complete Documentation
Accuprec provides structured documentation aligned with ISO standards and MDR expectations.

f. Single-Source Solution
Instead of coordinating between multiple labs and toxicologists, Accuprec provides both testing and TRA in one place.

7. Common Mistakes Companies Make in E&L and TRA

Accuprec helps manufacturers avoid common pitfalls such as:

• Using incomplete extraction conditions
• Incorrect selection of solvents
• Poor identification of unknown compounds
• Missing toxicological data
• Weak margin of safety calculations
• Lack of justification for risk acceptability
• Insufficient integration with biological evaluation

Accuprec’s experienced team ensures full compliance to avoid these issues.

Conclusion

Extractables and Leachables testing, along with Toxicological Risk Assessment, is essential for proving the chemical safety of medical devices. With stricter global regulations and increased focus on material characterization, manufacturers must invest in detailed chemical studies and strong toxicological justification.

Accuprec Research Labs offers complete ISO 10993-17/18 compliant E&L and TRA testing, supported by expert toxicologists, advanced analytical instruments and robust documentation. This helps manufacturers reduce regulatory risk, speed up approvals and ensure that their devices remain safe for patient use.

Accuprec is committed to supporting medical device companies with accurate testing and precise reporting, helping them confidently achieve global compliance.