The regulatory landscape for medical device biocompatibility continues to evolve. One of the most significant developments in 2026 is the U.S. Food and Drug Administration's (FDA) recognition of ISO 10993-1:2025, the latest edition of the internationally recognized standard for biological evaluation of medical devices.
Although biological evaluation has long been a cornerstone of medical device safety, the updated standard reinforces an important shift in regulatory expectations — from viewing biocompatibility as a series of laboratory tests to treating it as a comprehensive, risk-based scientific assessment throughout a device's lifecycle.
For medical device manufacturers planning FDA submissions or global market access, understanding these changes is essential.
Why ISO 10993-1 Matters
ISO 10993-1 provides the framework for evaluating whether materials used in a medical device could pose unacceptable biological risks to patients.
Rather than prescribing a fixed list of tests, the standard requires manufacturers to evaluate:
- Material composition
- Nature of body contact
- Duration of contact
- Manufacturing processes
- Chemical characterization
- Toxicological risks
- Clinical use
- Existing biological data
The outcome is a Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) that scientifically justify whether additional testing is necessary.
This risk-based philosophy aligns closely with modern regulatory expectations under both the FDA and the EU Medical Device Regulation (EU MDR).
What Changed in ISO 10993-1:2025?
While the overall structure of the standard remains familiar, the 2025 edition strengthens several important concepts that have gradually become industry best practices.
1. Greater Emphasis on Chemical Characterization
Perhaps the most notable trend is the continued prioritization of chemical characterization before biological testing.
Manufacturers are increasingly expected to understand:
- Extractable substances
- Leachable compounds
- Material impurities
- Manufacturing residues
- Processing aids
- Degradation products
Instead of automatically conducting animal studies, regulators increasingly expect manufacturers to determine whether sufficient chemical and toxicological evidence can answer biological safety questions.
This approach supports the principles of reducing unnecessary animal testing while improving scientific justification.
2. Biological Evaluation is a Continuous Process
The updated standard reinforces that biological evaluation is not a one-time activity performed before market approval. Instead, it should be maintained throughout the product lifecycle.
Manufacturers should reassess biological safety whenever significant changes occur, including:
- New suppliers
- Material substitutions
- Manufacturing process modifications
- Sterilization changes
- Packaging changes
- New clinical indications
This expectation closely mirrors lifecycle risk management principles already required under ISO 14971.
3. Better Integration with Risk Management
ISO 10993-1:2025 strengthens the relationship between biological evaluation and overall risk management. Rather than existing as separate documents, biological risks should now be integrated into the manufacturer's broader risk management process.
This includes:
- Hazard identification
- Exposure assessment
- Risk estimation
- Risk control
- Residual risk evaluation
The result is a more holistic safety assessment that considers both biological and non-biological hazards together.
4. Stronger Scientific Justification
Regulators increasingly expect manufacturers to explain why certain testing was or was not performed. Simply stating that a predicate device passed testing several years ago is rarely sufficient.
Instead, manufacturers should provide documented scientific rationale supported by:
- Material equivalence
- Literature reviews
- Toxicological assessments
- Historical clinical evidence
- Manufacturing controls
- Chemical characterization data
This documentation is becoming increasingly important during technical file reviews.
FDA Recognition Does Not Mean Automatic Acceptance
An important point that manufacturers should understand is that FDA recognition of a consensus standard does not mean every requirement is automatically accepted without question.
The FDA recognized ISO 10993-1:2025 with specific limitations and continues to evaluate biological safety based on the individual characteristics of each device.
Manufacturers should therefore avoid assuming that simple conformity with the standard guarantees regulatory acceptance. Instead, submissions should clearly explain:
- Device-specific risks
- Material selection rationale
- Testing strategy
- Risk assessment methodology
- Scientific evidence supporting conclusions
The FDA continues to emphasize scientific justification over checklist compliance.
What Does This Mean for EU MDR?
Although the FDA recognition specifically applies to U.S. submissions, its practical impact extends well beyond the United States.
EU MDR already places strong emphasis on comprehensive biological evaluation as part of Technical Documentation. Notified Bodies increasingly examine:
- Biological Evaluation Plans
- Biological Evaluation Reports
- Material characterization
- Chemical characterization reports
- Toxicological risk assessments
- Supplier controls
- Change management
Many of the expectations reinforced in ISO 10993-1:2025 are already reflected in current EU MDR assessments. Consequently, manufacturers developing documentation according to the updated standard may also strengthen their MDR submissions.
Practical Implications for Manufacturers
Medical device manufacturers should view this update as an opportunity to review their existing biological evaluation strategy. Key questions to consider include:
Is your Biological Evaluation Plan still current?
Many BEPs were developed several years ago and may no longer reflect current regulatory expectations.
Has your device changed since the last evaluation?
Even seemingly minor modifications — such as changing a supplier, adhesive, pigment, lubricant, or sterilization process — can alter the biological risk profile.
Are you relying on outdated test reports?
Legacy biological testing may not adequately support today's submissions if it lacks sufficient scientific justification or does not account for current manufacturing processes.
Is chemical characterization adequately documented?
Chemical characterization is becoming one of the most closely scrutinized aspects of biological evaluation. Incomplete extractables or toxicological assessments can delay regulatory review.
Does your risk management file align with your biological evaluation?
Regulators increasingly expect consistency between:
- Risk Management File
- Biological Evaluation Plan
- Biological Evaluation Report
- Clinical Evaluation
- Design documentation
Any inconsistencies may result in additional questions during review.
Looking Ahead
The recognition of ISO 10993-1:2025 reflects a broader regulatory trend toward evidence-based, scientifically justified biological evaluation.
Both FDA reviewers and EU Notified Bodies increasingly expect manufacturers to demonstrate a thorough understanding of how materials, manufacturing processes, chemical constituents, and clinical use collectively influence biological safety.
Rather than relying on extensive testing alone, successful regulatory submissions are likely to combine:
- Comprehensive chemical characterization
- Toxicological risk assessment
- Robust risk management
- Clear scientific justification
- Well-documented biological evaluation
Manufacturers who proactively update their biological evaluation processes to align with these expectations will be better positioned for efficient regulatory reviews and long-term compliance.
