NAMs for Medical Device Biocompatibility: FDA, EU & ISO 10993 Guide (2026)

NAMs for medical device biocompatibility: FDA roadmap, EU phase-out plan, ISO 10993-5/-10/-23 in vitro alternatives, chemical characterization, and regulatory strategy.

The Regulatory Arc Toward Animal-Free Biocompatibility Testing

Medical device manufacturers have relied on animal testing for biocompatibility evaluation since the earliest iterations of ISO 10993. For decades, the biological safety of implantable materials, surface coatings, leachables, and extractables has been assessed through in vivo studies -- rabbits for skin irritation, guinea pigs for sensitization, mice for systemic toxicity. These tests were embedded in the ISO 10993 framework and required by regulatory authorities worldwide as the default approach to demonstrating biological safety.

That paradigm is now shifting with unprecedented speed. In April 2025, the FDA published its "Roadmap to Reducing Animal Testing in Preclinical Safety Studies," a sweeping agency-wide initiative that explicitly targets the reduction and replacement of animal studies across all FDA-regulated product categories -- including medical devices. One year later, in April 2026, the agency followed with "Reducing Animal Testing in Nonclinical Studies: Year One Progress and the Path Forward," documenting concrete steps already taken and signaling accelerated adoption. In March 2026, FDA released the draft guidance "General Considerations for the Use of New Approach Methodologies in Drug Development" -- while CDER-focused, it is part of the broader agency posture toward NAMs. And on June 1, 2026, the European Commission published its own roadmap towards phasing out animal testing for chemical safety assessments, covering 15 legislative domains including medical device compatibility.

For the medical device industry, this convergence of regulatory action creates both opportunity and complexity. The opportunity is clear: in vitro methods, computational toxicology, and chemical characterization can provide equivalent or superior biological safety data while reducing cost, time, and ethical burden. The complexity lies in the fact that FDA and EU regulators do not yet agree on which NAMs are acceptable for which endpoints, ISO standards are still catching up with the regulatory ambition, and manufacturers must navigate a transition period where both animal and non-animal approaches coexist -- sometimes within the same biological evaluation plan.

This guide examines the current state of New Approach Methodologies for medical device biocompatibility: what NAMs are available today, where regulators stand on acceptance, how the ISO 10993 framework is evolving to accommodate non-animal approaches, and what manufacturers should do now to prepare for a testing landscape that is moving decisively away from in vivo studies.

What Are New Approach Methodologies (NAMs)?

New Approach Methodologies -- NAMs -- is an umbrella term for any technology, method, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment that avoids the use of intact animals. The term originated in the toxicology and chemical safety communities and has since been adopted by regulators worldwide, including the FDA, the European Commission, and the UK MHRA.

For medical devices, NAMs encompass several categories of alternative approaches:

In vitro methods: Cell-based assays that evaluate biological responses -- cytotoxicity, irritation, sensitization, genotoxicity -- without live animals. These range from well-established assays like the ISO 10993-5 direct contact cytotoxicity test to emerging reconstructed tissue models.
In chemico methods: Direct chemical analysis of device materials, extracts, and leachables. Chemical characterization under ISO 10993-18 is the foundational in chemico approach, providing data on what substances are present and at what concentrations, which can then be evaluated through toxicological risk assessment rather than animal testing.
Computational and in silico methods: Predictive toxicology using quantitative structure-activity relationship (QSAR) models, read-across approaches, and threshold of toxicological concern (TTC) frameworks. These are used in conjunction with chemical characterization data to assess risk from identified leachable substances.
Read-across and grouping approaches: Using existing toxicological data on structurally similar materials or substances to predict the behavior of a new material, reducing or eliminating the need for new testing.

For medical device biocompatibility specifically, the most practically important NAMs are chemical characterization (ISO 10993-18 combined with toxicological risk assessment under ISO 10993-17) and in vitro alternatives to the standard biological endpoint tests. These are not theoretical possibilities -- they are methods being used today by manufacturers who understand the regulatory framework and can justify their approach.

FDA's Evolving Position on NAMs for Medical Devices

The CDRH Foundation: 3Rs and Chemical Characterization First

The FDA's Center for Devices and Radiological Health (CDRH) has been encouraging the use of non-animal approaches for medical device biocompatibility since well before the 2025 roadmap. The agency's biocompatibility guidance -- most recently updated in 2023 as "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process'" -- explicitly supports the 3Rs approach (replace, reduce, refine) and encourages manufacturers to prioritize chemical characterization over animal testing wherever scientifically justified.

This 2023 guidance established several key principles that remain the foundation of FDA's approach to NAMs in device biocompatibility:

Biological evaluation should be conducted within the framework of a risk management process per ISO 14971, not as a checklist of required tests
Chemical characterization of device materials and extracts should be performed before considering biological testing
When chemical characterization and toxicological risk assessment can adequately address a biological endpoint, additional biological testing (including animal testing) may not be necessary
Animal testing should be considered only when non-animal approaches cannot adequately address the biological safety question

CDRH has also promoted NAMs through the Medical Device Development Tools (MDDT) program, which provides a formal pathway for qualifying new methodologies -- including non-animal test methods -- for use in medical device regulatory submissions. A NAM qualified through the MDDT program has been reviewed by FDA and found to produce valid, reliable results for its intended use, giving manufacturers confidence that FDA will accept data generated using the qualified method.

The 2025 Roadmap: Agency-Wide Commitment

The FDA's April 2025 "Roadmap to Reducing Animal Testing in Preclinical Safety Studies" elevated the NAMs discussion from a center-level initiative to an agency-wide priority. The roadmap committed FDA to:

Encouraging the development and validation of NAMs across all product areas
Updating guidance documents to reflect the acceptance of NAMs where scientifically appropriate
Working with international regulatory counterparts to align on NAMs acceptance criteria
Prioritizing NAMs in the review of preclinical data packages

For medical device manufacturers, the roadmap signaled that CDRH's existing encouragement of non-animal approaches would intensify, and that FDA reviewers would increasingly expect manufacturers to justify why animal testing is necessary rather than assuming it is the default.

The 2026 Year One Report: Progress and Acceleration

The April 2026 "Year One Progress" report documented tangible actions taken in the first year of the roadmap. While much of the visible progress has been in drug development (the March 2026 draft NAMs guidance from CDER being the most prominent example), CDRH has continued to advance NAMs for devices through the MDDT program, through reviewer training on chemical characterization-based approaches, and through engagement with ISO working groups developing new in vitro test standards.

The year one report also emphasized FDA's intention to issue device-specific guidance on NAMs acceptance in the near term, potentially covering which in vitro methods can be used as replacements for specific in vivo biocompatibility endpoints.

The EU Commission Roadmap: Phasing Out Animal Testing

On June 1, 2026, the European Commission published its roadmap towards phasing out animal testing for chemical safety assessments. This is a landmark document for the medical device industry because it explicitly includes "medical device compatibility" among the 15 legislative domains covered by the roadmap.

Scope and Ambition

The EC roadmap is built around three pillars:

Making change happen -- Legislative and regulatory actions to mandate or incentivize the use of NAMs, including updating regulations to accept NAMs data, removing requirements for animal testing where alternatives exist, and establishing validation pathways for new methods.
Keeping Europe at the forefront -- Continued investment in NAMs research and development. The European Commission has invested nearly 1.5 billion euros in alternative testing research over the past two decades, and the roadmap commits to sustaining and expanding this investment.
Working together -- International collaboration on NAMs validation and acceptance, engagement with industry and civil society, and coordination across EU member states and agencies.

The inclusion of medical devices in the roadmap is significant because the EU has historically been more aggressive than the US in accepting in vitro alternatives. The EU has accepted the in vitro skin irritation test (ISO 10993-23 using reconstructed human epidermis models) for several years, while the FDA has not yet recognized it as a standalone replacement for the in vivo rabbit skin irritation test.

Implications for Device Manufacturers

For manufacturers marketing devices in the EU, the roadmap signals that the European regulatory environment will become increasingly favorable toward NAMs-based biological evaluation. Notified Bodies will be expected to accept appropriately validated non-animal methods, and the regulatory framework will evolve to require justification for animal testing rather than justification for using NAMs.

However, the transition period creates a practical challenge for manufacturers who market devices globally. A biological evaluation plan that is acceptable to EU Notified Bodies using in vitro methods may not satisfy FDA reviewers who still expect certain in vivo endpoints. This divergence -- and how to manage it -- is one of the central strategic questions facing device manufacturers today.

ECHA and Validation Infrastructure

The European Chemicals Agency (ECHA) and other EU agencies are actively developing validation pathways for NAMs, building on the established ECVAM (European Centre for the Validation of Alternative Methods) framework. For medical device manufacturers, this validation infrastructure will eventually provide the standardized, internationally recognized test methods that regulators require -- but the process of developing, validating, and codifying new methods takes years, and the pipeline of NAMs currently under validation does not yet cover all biocompatibility endpoints required by ISO 10993.

ISO 10993 Framework: Where NAMs Fit Today

The ISO 10993 series of standards provides the technical framework for biological evaluation of medical devices. Several parts of the standard are directly relevant to the NAMs discussion, and the framework is evolving to accommodate the shift away from animal testing.

ISO 10993-1:2025 -- The Overarching Standard

The latest edition of ISO 10993-1, published in 2025, places greater emphasis than ever on minimizing animal testing and prioritizing in vitro and chemical characterization approaches. The standard reinforces the principle that biological evaluation should begin with material characterization and physical and chemical testing, proceed to in vitro biological assays, and resort to in vivo testing only when the preceding steps cannot adequately address the biological safety question.

This hierarchy is not new -- ISO 10993-1 has always endorsed a stepwise approach -- but the 2025 edition strengthens the language and makes the expectation of minimizing animal testing more explicit. For manufacturers, this means that biological evaluation plans that default to animal testing without first exhausting non-animal approaches are increasingly out of step with the standard.

ISO 10993-2: Animal Welfare Requirements

ISO 10993-2, "Animal welfare requirements," establishes the ethical framework for animal testing in biological evaluation. The standard requires that animal studies be conducted in accordance with the 3Rs principles, that the number of animals used be minimized, and that alternatives be considered before any in vivo study is initiated. As NAMs become more widely accepted, ISO 10993-2's requirements increasingly push manufacturers toward non-animal approaches.

ISO 10993-18 and ISO 10993-17: The Core Non-Animal Pathway

Chemical characterization (ISO 10993-18) combined with toxicological risk assessment (ISO 10993-17) is the most mature and widely accepted non-animal approach to biocompatibility evaluation. This pathway does not involve biological testing at all -- instead, it relies on:

Chemical characterization of device materials and extracts using analytical techniques such as gas chromatography-mass spectrometry (GC-MS), liquid chromatography-mass spectrometry (LC-MS), inductively coupled plasma mass spectrometry (ICP-MS), and Fourier-transform infrared spectroscopy (FTIR). The goal is to identify and quantify all substances that could potentially be released from the device during patient contact.
Toxicological risk assessment of each identified substance, comparing estimated patient exposure to established safety thresholds such as the tolerable intake (TI), the threshold of toxicological concern (TTC), or compound-specific safety data from the literature. If all substances are present at levels below their respective safety thresholds, the risk is considered acceptable without the need for biological testing.

This approach is accepted by both FDA and EU regulators and is the single most powerful NAM available to device manufacturers today. When executed rigorously, chemical characterization plus toxicological risk assessment can eliminate the need for many biological tests, including systemic toxicity, genotoxicity, carcinogenicity, and reproductive and developmental toxicity -- endpoints that traditionally required extensive animal studies.

The key limitation is that chemical characterization requires a comprehensive understanding of device materials and manufacturing processes. Incomplete characterization -- failing to identify a significant leachable substance -- undermines the entire approach. Manufacturers must invest in thorough analytical work and ensure that their characterization covers all relevant extractables under conditions that simulate clinical use.

ISO 10993-5: Cytotoxicity -- Fully In Vitro

Cytotoxicity testing under ISO 10993-5 is already a fully in vitro assay. The standard provides three methods -- extract dilution, direct contact, and indirect contact (agar diffusion) -- all of which use cultured mammalian cells rather than animals. Cell viability is assessed through metrics such as membrane integrity, mitochondrial function, or metabolic activity.

Because cytotoxicity testing is already in vitro, it is not a focus of the NAMs transition -- it is already a NAM. But it illustrates an important principle: in vitro methods have been part of the standard biocompatibility testing battery for decades, and the current NAMs initiative is about extending this approach to endpoints that currently require animals, not introducing an entirely new paradigm.

ISO 10993-23: Irritation -- In Vitro Options Exist but Regulatory Acceptance Varies

ISO 10993-23, "Tests for irritation," includes in vitro test methods using reconstructed human epidermis (RhE) tissue models. These models use cultured human keratinocytes that differentiate into a multilayered epidermis with a functional stratum corneum, closely mimicking human skin. The in vitro irritation test measures cell viability in the RhE model after exposure to device extracts, using the same MTT reduction assay used in the validated in vitro skin irritation method for chemicals under OECD TG 439.

Here is where the regulatory picture becomes complex:

EU acceptance: EU regulators accept the in vitro RhE-based irritation test under ISO 10993-23 as a replacement for the in vivo rabbit skin irritation test. Manufacturers submitting to EU Notified Bodies can use in vitro irritation data to fulfill the irritation endpoint without conducting animal studies.
FDA non-acceptance: The FDA does not currently recognize the in vitro ISO 10993-23 method as a standalone replacement for in vivo irritation testing. FDA reviewers may consider in vitro irritation data as supporting information, but they have not accepted it as sufficient on its own. This means that manufacturers seeking FDA clearance or approval for devices requiring irritation testing still need to either conduct the in vivo test or provide a robust scientific justification for why the in vitro data are adequate -- a justification that, in practice, has not been consistently successful.

This divergence is one of the most significant transatlantic differences in NAMs acceptance for device biocompatibility, and it directly affects manufacturers who market devices in both the US and EU.

ISO 10993-10: Sensitization -- In Vitro Methods Available but Not Yet Equivalent

Sensitization testing (ISO 10993-10) presents the most challenging NAMs landscape among the standard biocompatibility endpoints. The traditional in vivo methods -- the Guinea Pig Maximization Test (GPMT) and the Murine Local Lymph Node Assay (LLNA) -- remain the reference standards for assessing the skin sensitization potential of medical device materials and extracts.

In vitro methods for sensitization are under active development, including the Direct Peptide Reactivity Assay (DPRA), KeratinoSens, h-CLAT, and the integrated testing strategy (IATA) approach that combines multiple in vitro assays. However, FDA does not currently consider these in vitro methods equivalent to the in vivo tests for medical device applications. The scientific challenge is that sensitization is a complex immunological process involving protein haptenation, dendritic cell activation, and T-cell proliferation -- a multi-step cascade that is difficult to recapitulate in a single in vitro assay.

The EU is further along in considering in vitro sensitization data, but even in Europe, full replacement of in vivo sensitization testing for medical devices has not yet been achieved. The EC roadmap's inclusion of medical device compatibility signals that this is a priority for future development.

The UK MHRA: Signals of Alignment on NAMs

On March 25, 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on its approach to assessing applications for medicines that use non-animal methods. While this guidance applies to medicinal products rather than medical devices specifically, it signals the MHRA's broader institutional commitment to accepting NAMs data and reducing reliance on animal studies across all product categories.

For medical device manufacturers, the MHRA has not yet issued dedicated guidance on NAMs for biocompatibility testing. However, the UK's post-Brexit regulatory framework for devices generally aligns with EU principles, and the UK accepts CE-marked devices under transitional provisions. This means that devices approved in the EU using in vitro methods under ISO 10993-23 can typically be placed on the UK market under the same evidence base. Manufacturers marketing devices in the UK should monitor MHRA communications for device-specific NAMs guidance, which is expected as the global regulatory momentum toward non-animal methods continues to build.

FDA vs. EU: Where the Divergence Matters Most

The practical impact of the transatlantic NAMs divergence depends on which biocompatibility endpoints are required for a given device. The following table summarizes the current regulatory status:

Endpoint	ISO Standard	In Vitro Method Available	EU Acceptance	FDA Acceptance
Cytotoxicity	ISO 10993-5	Yes (already in vitro)	Accepted	Accepted
Irritation	ISO 10993-23	Yes (RhE models)	Accepted as replacement	Not accepted as standalone replacement
Sensitization	ISO 10993-10	Partially (DPRA, KeratinoSens, h-CLAT)	Under consideration	Not accepted as equivalent
Systemic toxicity	ISO 10993-11	No validated in vitro replacement	Chemical characterization may substitute	Chemical characterization may substitute
Genotoxicity	ISO 10993-3	Yes (Ames, mouse lymphoma, chromosomal aberration -- already in vitro)	Accepted	Accepted
Hemocompatibility	ISO 10993-4	Partially (some tests in vitro)	Partial acceptance	Partial acceptance
Carcinogenicity	ISO 10993-3	No validated in vitro replacement	Chemical characterization may substitute	Chemical characterization may substitute
Reproductive/developmental	ISO 10993-3	No validated in vitro replacement	Chemical characterization may substitute	Chemical characterization may substitute
Implantation	ISO 10993-6	No validated in vitro replacement	Animal testing generally required	Animal testing generally required

The critical divergence points are irritation and sensitization -- two of the three tests in the standard biocompatibility test battery. For manufacturers of surface-contacting and externally communicating devices, these are often the primary biological endpoints requiring assessment, and the inability to use in vitro methods for FDA submissions means that animal testing remains necessary for the US market even as it becomes avoidable for the EU.

Practical Strategy: Building a NAMs-Based Biological Evaluation Plan

For manufacturers seeking to reduce or eliminate animal testing in their biological evaluation, the following approach reflects the current state of regulatory acceptance and scientific capability:

Step 1: Invest in Comprehensive Chemical Characterization

Chemical characterization under ISO 10993-18 is the single most impactful step a manufacturer can take toward reducing animal testing. A thorough chemical characterization program should include:

Full material disclosure from suppliers, including all additives, processing aids, colorants, and residuals
Extractables studies using both polar and non-polar solvents under exaggerated and simulated-use conditions
Analytical techniques sufficient to identify and quantify all extractables, including non-targeted analysis for unexpected substances
Leachables studies where clinically relevant, simulating actual patient exposure conditions

The more complete the chemical characterization, the more biological endpoints can be addressed through toxicological risk assessment (ISO 10993-17) rather than biological testing. A comprehensive chemical characterization dataset can potentially eliminate the need for systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity testing.

Step 2: Use In Vitro Methods Where Accepted by Both Regulators

Cytotoxicity (ISO 10993-5) is fully accepted as an in vitro test by both FDA and EU regulators. It should be included in every biological evaluation plan as a baseline screening assay. The genotoxicity test battery (Ames test, mouse lymphoma assay, chromosomal aberration assay) is also fully in vitro and accepted by both regulatory systems.

Step 3: Apply In Vitro Irritation for EU-Only Submissions

For devices marketed exclusively in the EU, the in vitro irritation test under ISO 10993-23 using RhE models is accepted as a replacement for the rabbit skin irritation test. Manufacturers should use this method to eliminate animal testing for the irritation endpoint in EU submissions.

For devices marketed globally (US and EU), the manufacturer must decide between conducting the in vivo irritation test (acceptable to both regulators) or conducting the in vitro test (acceptable to EU, potentially challengeable at FDA). In practice, many manufacturers choose to conduct the in vivo test to maintain a single global test dataset, even though this means forgoing the animal-free approach for the EU submission.

Step 4: Develop a Robust Scientific Justification for NAMs-Based Approaches

Even where FDA has not formally accepted a specific in vitro method, manufacturers can submit a scientific justification for using NAMs data in lieu of animal testing. This justification should include:

Evidence of the validity and reliability of the in vitro method for the specific application
Correlation data showing that the in vitro method produces results consistent with in vivo data for similar materials
A rationale explaining why the in vitro method is appropriate for the specific device and biological endpoint
Any supporting data from published literature or prior regulatory submissions

This approach is not guaranteed to succeed, and manufacturers should engage with FDA early -- through the Pre-Submission (Q-Submission) process -- to gauge reviewer receptivity before committing to a NAMs-only testing strategy for a US submission.

Step 5: Leverage the MDDT Program for Method Qualification

The FDA's Medical Device Development Tools (MDDT) program provides a formal pathway for qualifying NAMs for use in device regulatory submissions. A manufacturer or test method developer can submit an MDDT qualification package to FDA, demonstrating that the method produces valid scientific evidence for its intended use. Once qualified, the method can be used by any manufacturer in FDA submissions without additional justification.

For the NAMs community, the MDDT program is an underutilized but powerful mechanism for advancing the acceptance of non-animal methods. Qualifying a new in vitro method through the MDDT program requires a significant investment of time and data, but it creates a durable regulatory precedent that benefits the entire industry.

Step 6: Monitor and Prepare for Evolving Standards

The ISO 10993 series is actively being revised to incorporate NAMs. ISO 10993-1:2025 has already strengthened the emphasis on minimizing animal testing. Future revisions of ISO 10993-10 (sensitization) and ISO 10993-23 (irritation) are expected to expand in vitro options and potentially establish validated in vitro methods as the primary approach for these endpoints.

Manufacturers should participate in the standards development process through their national standards bodies, track ISO working group activities, and be prepared to update their biological evaluation procedures as new editions are published.

The MDDT Program in Detail

The FDA's Medical Device Development Tools program was established to provide a structured pathway for qualifying tools used in medical device development -- including non-clinical test methods, clinical outcome assessments, and biomarkers. For NAMs in biocompatibility, the MDDT program is particularly relevant because it offers a way to obtain FDA endorsement of a specific non-animal test method for a defined context of use.

The MDDT qualification process involves:

Submission of a qualification package that describes the tool, its intended use, the evidence supporting its validity and reliability, and the context in which it will be used
FDA review of the package, including evaluation of the supporting data, the appropriateness of the method for the intended use, and the strength of the evidence
Qualification decision by FDA, which, if positive, means that the tool is recognized as producing valid scientific evidence for its qualified use

Once a NAM is qualified as an MDDT, FDA reviewers are expected to accept data generated using the qualified method without requiring additional justification from the manufacturer. This does not mean the method is mandatory -- manufacturers can still use other approaches -- but it provides a clear regulatory pathway for NAMs-based biological evaluation.

To date, the MDDT program has qualified a limited number of tools, and no in vitro biocompatibility test method has been qualified as a direct replacement for an in vivo test. However, the program is actively seeking submissions, and the FDA's roadmap signals that the agency wants to accelerate MDDT qualifications for NAMs. For test method developers and forward-looking manufacturers, the MDDT program represents the most direct route to establishing regulatory acceptance of non-animal methods for device biocompatibility.

Timeline and Outlook

The transition from animal testing to NAMs in medical device biocompatibility is not a single event but a phased process. Based on current regulatory signals, standardization activities, and the pace of method development, the following timeline provides a reasonable outlook:

2025-2026 (Current Phase): Regulatory frameworks and roadmaps are being established. Chemical characterization plus toxicological risk assessment is the primary NAMs pathway accepted by both FDA and EU regulators. In vitro cytotoxicity and genotoxicity are fully accepted. In vitro irritation is accepted in the EU but not by FDA. In vitro sensitization methods are available but not accepted by either regulator for medical devices as standalone replacements. Manufacturers should be building chemical characterization capabilities and engaging with the MDDT program.

2027-2028: Expect FDA to issue updated guidance or draft guidance specifically addressing in vitro irritation and sensitization methods for device biocompatibility. ISO working groups are likely to advance revised standards incorporating validated in vitro methods for sensitization. EU regulators will be implementing the EC roadmap, potentially updating the MDR and associated guidance to explicitly favor NAMs. The number of MDDT-qualified NAMs should increase.

2029-2031: As validation data accumulates and international alignment improves, expect broader acceptance of in vitro methods for irritation and sensitization by both FDA and EU regulators. Chemical characterization-based approaches will become the default starting point for biological evaluation, with animal testing required only for endpoints where no validated NAM exists (primarily implantation). The ISO 10993 framework will reflect this shift, with revised standards establishing in vitro methods as primary approaches for most endpoints.

Beyond 2031: Complete replacement of animal testing for device biocompatibility will depend on the development of validated in vitro or computational methods for the remaining challenging endpoints -- particularly local effects following implantation. This is the most scientifically difficult frontier, as implantation testing evaluates tissue response to a physical device in a biological environment over extended time periods, a scenario that is inherently difficult to model in vitro. Progress will depend on advances in tissue engineering, organ-on-a-chip technology, and computational modeling.

The Strategic Imperative

The regulatory direction is unambiguous: both the FDA and the European Commission are committed to reducing and ultimately replacing animal testing for medical device biocompatibility. The question for manufacturers is not whether this transition will happen, but how to position themselves to navigate it effectively.

Manufacturers who invest now in chemical characterization capabilities, develop expertise in toxicological risk assessment, and engage proactively with the MDDT program and the evolving ISO standards will be ahead of the curve. Those who continue to default to animal testing without first exploring non-animal alternatives will find themselves increasingly out of step with both the regulatory expectations and the ethical standards of the industry.

The practical reality of 2026 is that NAMs cannot yet replace all animal testing for device biocompatibility. But they can replace a significant portion of it -- and the portion that can be addressed without animals is growing every year. The manufacturers who recognize this and adapt their biological evaluation strategies accordingly will reduce costs, accelerate timelines, and be better prepared for the regulatory environment of the late 2020s and beyond.