Notified Bodies and the EU AI Act: Your Essential Guide to Third-Party Assessment

Introduction: Your Essential Partners in AI Act Compliance

As we move through September 2025, with less than a year until the EU AI Act's high-risk provisions take full effect in August 2026, one question keeps arising in boardrooms and development teams across Europe and beyond: "How do we actually prove our AI system is compliant?" The answer, for many organizations, lies in understanding and partnering with notified bodies—the specialized organizations that will serve as gatekeepers to the European AI market.

If you're feeling a bit overwhelmed by the prospect of working with notified bodies, you're not alone. These organizations represent a new layer in the AI compliance ecosystem, and their role in the EU AI Act introduces requirements that many AI developers haven't encountered before. But here's the reassuring news: notified bodies aren't adversaries or bureaucratic obstacles. They're expert partners designed to help ensure that AI systems meet the high standards European citizens expect while enabling innovation to flourish.

This comprehensive guide will demystify notified bodies in the context of the EU AI Act, explaining not just what they are and what they do, but how to work with them effectively. Whether you're preparing for your first conformity assessment or trying to understand if you'll need a notified body at all, this article provides the practical insights you need to navigate this crucial aspect of AI Act compliance with confidence.

What Are Notified Bodies? Understanding Their Role and Purpose

The Foundation: A Proven Concept Applied to AI

Notified bodies aren't a new invention created for the AI Act. They're part of a well-established European regulatory framework that has successfully ensured product safety and compliance across industries for decades. From medical devices to machinery, from toys to telecommunications equipment, notified bodies have been the independent third parties that verify products meet EU standards before they reach consumers.

In the context of the EU AI Act, notified bodies serve as independent conformity assessment bodies designated by EU member states to evaluate whether high-risk AI systems comply with the Act's requirements. Think of them as specialized auditors with deep technical expertise in AI systems, combining regulatory knowledge with practical understanding of artificial intelligence technologies. They bridge the gap between regulatory requirements and technical implementation, providing objective assessment that builds trust in AI systems.

What makes notified bodies particularly valuable is their independence. They're not government agencies (though they're designated by governments), and they're not consultants working for AI developers. This independence ensures objective assessment while maintaining practical, industry-aware perspectives. They understand both the letter and the spirit of the law, helping organizations not just tick compliance boxes but build genuinely trustworthy AI systems.

Core Responsibilities Under the AI Act

Notified bodies under the AI Act carry several critical responsibilities that go beyond simple pass/fail assessments. Their primary role involves conducting conformity assessments for certain categories of high-risk AI systems, but this encompasses a range of activities designed to ensure comprehensive evaluation of AI system compliance.

First and foremost, notified bodies evaluate technical documentation to ensure it completely and accurately describes the AI system, its intended purpose, and its compliance measures. This isn't just a paperwork review—it's a deep dive into how the AI system works, how it was developed, what data it uses, and how risks are managed. They assess whether the documentation would enable another expert to understand and evaluate the system independently.

Beyond documentation, notified bodies conduct practical assessments of AI systems themselves. This might involve testing the system's performance against its stated specifications, evaluating its behavior in various scenarios, assessing the effectiveness of human oversight mechanisms, and verifying that transparency requirements are met. For AI systems that continue learning after deployment, they also evaluate how post-market performance will be monitored and managed.

Importantly, notified bodies also play an ongoing role after initial certification. They conduct surveillance activities to ensure continued compliance, assess substantial modifications that might affect conformity, and can suspend or withdraw certificates if systems no longer meet requirements. This ongoing relationship helps ensure that compliance isn't just achieved once but maintained throughout the AI system's lifecycle.

When Do You Need a Notified Body? Navigating Assessment Requirements

Mandatory Third-Party Assessment Categories

Not all high-risk AI systems require notified body involvement. The EU AI Act carefully delineates which systems must undergo third-party assessment and which can use self-assessment procedures. Understanding these distinctions is crucial for compliance planning and can significantly impact your timeline and budget.

Biometric identification and categorization systems represent the most clear-cut category requiring notified body assessment. Any AI system that identifies or categorizes natural persons based on biometric data—whether for remote identification, emotion recognition, or biometric categorization—must undergo third-party conformity assessment. This requirement reflects the particular sensitivity and fundamental rights implications of biometric technologies.

AI systems used as safety components of products covered by existing EU product legislation also require notified body assessment when that legislation already requires third-party assessment. This includes AI systems in medical devices, automotive systems, machinery, toys, and various other product categories. The AI Act integrates with existing regulatory frameworks rather than replacing them, ensuring consistency across different types of products incorporating AI.

For AI systems that fall under both the AI Act and existing product legislation, the conformity assessment can often be conducted as part of a single procedure under the relevant product legislation, updated to include AI Act requirements. This integration helps avoid duplicate assessments while ensuring all applicable requirements are met.

Optional Self-Assessment Routes

Many high-risk AI systems listed in Annex III of the AI Act can choose between notified body assessment and self-assessment, provided certain conditions are met. This flexibility recognizes that organizations with robust internal processes and expertise may be capable of conducting thorough self-assessment while maintaining compliance standards.

Self-assessment is available when harmonized standards exist and the AI provider has applied them in full. These standards, once published, will provide detailed technical specifications for meeting AI Act requirements. By fully implementing these standards, organizations can demonstrate presumption of conformity without third-party assessment. However, this route requires meticulous documentation and internal quality assurance processes.

Even when self-assessment is technically permitted, many organizations may choose voluntary notified body involvement for several strategic reasons. Third-party certification can provide stronger market credibility, reduce liability concerns, offer expert validation of compliance approaches, and facilitate international market access. For organizations without deep AI regulatory expertise, notified body assessment may actually be more efficient than building internal assessment capabilities.

Special Cases and Exceptions

Several special cases affect when and how notified body assessment applies. General-purpose AI models, even those with systemic risk, don't require notified body assessment for the model itself, though systems built on these models might. Research and development activities are generally exempt, provided the AI system isn't placed on the market or put into service.

Small-scale providers, including startups and SMEs, benefit from certain accommodations in the assessment process. While they're not exempt from notified body requirements where applicable, they may access reduced fees, priority processing in some member states, and additional support through regulatory sandboxes. These measures help ensure that compliance requirements don't create insurmountable barriers for smaller innovators.

Military and national security applications fall outside the AI Act's scope entirely, as do AI systems used exclusively for personal non-professional activities. However, dual-use systems that have both civilian and military applications must comply with AI Act requirements for their civilian uses.

The Designation and Qualification of Notified Bodies

The Designation Process: Ensuring Excellence

Notified bodies don't simply declare themselves qualified to assess AI systems—they undergo a rigorous designation process managed by EU member states and overseen by the European Commission. This process ensures that every notified body meets stringent requirements for competence, independence, and operational capability.

The designation process begins with an application to the relevant national authority in an EU member state. Applicant organizations must demonstrate technical competence in AI and related technologies, including machine learning, data science, software engineering, and relevant application domains. They need appropriate organizational structure and procedures, sufficient personnel with necessary qualifications and experience, and independence from AI developers and providers.

National authorities conduct thorough assessments of applicants, often involving document reviews, on-site audits, witness assessments, and competence testing. The process typically takes 6-12 months and may involve peer review by other member states' authorities. Once designated, notified bodies are listed in the European Commission's NANDO (New Approach Notified and Designated Organizations) database, making them visible to all potential clients.

Required Competencies and Expertise

The competencies required for AI Act notified bodies go significantly beyond traditional product certification expertise. These organizations must combine deep technical knowledge of AI systems with understanding of regulatory requirements, risk assessment methodologies, and fundamental rights implications.

Technical competencies must cover the full spectrum of AI technologies and applications. This includes expertise in various machine learning approaches and algorithms, data quality and governance practices, model training, validation, and testing methodologies, explainability and interpretability techniques, and cybersecurity and robustness testing. Notified bodies need personnel who understand not just how AI systems work in theory but how they behave in practice.

Beyond technical skills, notified bodies must demonstrate regulatory and assessment expertise. This encompasses understanding of the AI Act and related legislation, risk assessment and management methodologies, quality management systems, technical documentation requirements, and post-market monitoring approaches. They must be able to evaluate not just whether an AI system meets specific technical requirements but whether it achieves the Act's broader goals of trustworthiness and fundamental rights protection.

Equally important are soft skills and operational capabilities. Notified bodies must maintain impartiality and manage conflicts of interest, communicate effectively with diverse stakeholders, handle confidential information appropriately, and stay current with rapidly evolving AI technologies. They need robust quality management systems, clear procedures, and sufficient resources to handle their assessment workload while maintaining high standards.

Monitoring and Oversight Mechanisms

The designation of notified bodies isn't a one-time event but the beginning of ongoing monitoring and oversight. Multiple mechanisms ensure that notified bodies maintain their competence and performance standards throughout their designation period.

National authorities conduct regular surveillance of their designated notified bodies, typically including annual audits, performance monitoring, and complaint investigation. These activities verify that notified bodies maintain their competencies, follow appropriate procedures, make consistent and appropriate conformity decisions, and address any identified non-conformities. Surveillance may involve reviewing assessment reports, witnessing actual assessments, and interviewing personnel and clients.

The European Commission and member states also coordinate horizontal oversight through the AI Act's governance structure. This includes peer evaluation between notified bodies, coordination groups that harmonize assessment approaches, and sharing of best practices and interpretations. This collaborative approach helps ensure consistency across the EU while allowing for continuous improvement in assessment methodologies.

Working with Notified Bodies: A Practical Guide

Selecting the Right Notified Body

Choosing a notified body is one of the most important decisions in your conformity assessment journey. While all notified bodies must meet the same designation requirements, they may differ in their specific expertise, capacity, approach, and commercial terms. Making the right choice can significantly impact your assessment experience and timeline.

Start by identifying notified bodies with relevant domain expertise. If your AI system operates in healthcare, look for bodies with medical device experience. For automotive AI, seek those familiar with vehicle type approval. Domain expertise helps ensure that assessors understand your application context and can provide more valuable insights during assessment. Check the NANDO database for bodies designated for AI Act assessments and review their stated competencies.

Consider practical factors like language, location, and capacity. While notified bodies can operate across the EU, working with one that speaks your language and understands your market can facilitate communication. Geographic proximity might matter if on-site assessments are required. Most importantly, verify that your chosen body has capacity to meet your timeline—as August 2026 approaches, the most experienced bodies may face capacity constraints.

Don't hesitate to interview multiple notified bodies before making your selection. Ask about their assessment methodology, typical timelines, fee structures, and support services. Request references from similar organizations they've worked with. Remember, you're not just purchasing a service but entering a potentially long-term relationship that will continue through surveillance and reassessment activities.

Preparing for Assessment: Building Your Foundation

Successful conformity assessment doesn't begin when you submit your application—it starts months earlier with thorough preparation. Organizations that approach assessment well-prepared typically experience smoother, faster, and less costly processes than those who treat it as an afterthought.

Technical documentation forms the cornerstone of your assessment preparation. Begin developing your documentation early, ideally as part of your development process rather than retroactively. Your documentation should tell the complete story of your AI system: what it does, how it works, why design decisions were made, what risks exist, and how they're managed. Remember that your documentation will be reviewed by experts who don't know your system, so clarity and completeness are essential.

Conduct your own gap analysis before engaging a notified body. Review each AI Act requirement applicable to your system and honestly assess your compliance. Where gaps exist, develop remediation plans with realistic timelines. This self-assessment helps you identify and address issues before formal assessment, potentially saving significant time and cost. Consider engaging consultants or conducting pre-assessments if you're unsure about your readiness.

Establish your quality management system well before assessment. This isn't just about having procedures on paper but embedding quality practices into your organization's DNA. Train your team on relevant procedures, conduct internal audits to verify implementation, maintain records that demonstrate ongoing compliance, and establish feedback loops for continuous improvement. A mature quality system makes assessment much smoother and demonstrates your commitment to ongoing compliance.

The Assessment Process: What to Expect

Understanding what happens during conformity assessment helps you prepare effectively and manage stakeholder expectations. While specific procedures vary by module and notified body, most assessments follow a similar overall structure designed to thoroughly evaluate compliance while maintaining efficiency.

The process typically begins with an application and preliminary review. You'll submit basic information about your AI system and organization, along with initial documentation. The notified body reviews this to ensure the assessment falls within their scope and competence, understand the system's complexity and risk level, identify any obvious gaps requiring attention, and develop an assessment plan with timelines and resource requirements. This stage might include a pre-assessment meeting to clarify requirements and expectations.

The main assessment phase involves deep documentary review and may include technical evaluation. Documentary review goes beyond checking that documents exist—assessors evaluate whether documentation accurately reflects the system, requirements are properly addressed, risk assessments are comprehensive and appropriate, and testing validates claimed performance. For certain systems, assessors may conduct their own testing or witness your testing procedures. This phase typically involves multiple rounds of questions and clarifications.

Following assessment, the notified body makes a conformity decision. If positive, they issue appropriate certificates or attestations that enable CE marking and market placement. If negative, they provide detailed feedback on non-conformities requiring resolution. Most negative decisions can be addressed through remediation and reassessment of specific issues rather than starting over completely. Remember that assessment isn't adversarial—notified bodies want to see compliant systems succeed.

Managing the Ongoing Relationship

Certification marks the beginning, not the end, of your relationship with your notified body. The AI Act requires ongoing surveillance to ensure continued compliance, and managing this relationship effectively is crucial for long-term success.

Surveillance activities typically occur annually but may vary based on risk level and performance history. These aren't full reassessments but targeted reviews focusing on changes since certification, post-market performance data, incident reports and corrective actions, and quality system effectiveness. Prepare for surveillance by maintaining clear records of all changes and improvements, documenting how you've addressed any issues identified, and demonstrating continuous improvement in your compliance processes.

Keep your notified body informed about significant changes to your AI system or organization. Substantial modifications might require reassessment before implementation. Even minor changes should be documented and communicated according to agreed procedures. This transparency helps prevent compliance surprises and maintains trust in the relationship. Your notified body can also provide valuable guidance on whether planned changes affect conformity.

View your notified body as a partner, not just an assessor. They can provide valuable insights into regulatory interpretations, industry best practices, and emerging requirements. Many offer training, newsletters, or other resources to keep clients informed. While they can't provide consulting on how to achieve compliance (that would compromise their independence), they can clarify requirements and share anonymized lessons from other assessments.

Timeline and Cost Considerations

Realistic Timeline Planning

With August 2026 approaching, timeline management has become critical for organizations requiring notified body assessment. Understanding realistic timelines helps you plan effectively and avoid costly rushes as deadlines approach.

Initial designation of sufficient notified bodies is still ongoing as of September 2025. While some bodies already have designation for related areas (like medical devices), specific AI Act designation takes time. Industry estimates suggest that full capacity won't be available until early 2026, creating potential bottlenecks for organizations needing assessment. This makes early engagement even more critical—don't wait until notified bodies are fully designated to begin preparing.

The assessment process itself typically takes 3-6 months for well-prepared organizations, but this can extend to 9-12 months if significant gaps exist. This timeline includes application and contracting (2-4 weeks), documentary review and clarifications (6-12 weeks), technical assessment if required (4-8 weeks), decision and certification (2-4 weeks), and administrative finalization (1-2 weeks). Remember that these are elapsed times—calendar duration may be longer depending on your responsiveness and the notified body's capacity.

Build buffer time into your compliance planning. Assume that you'll need at least one round of remediation and reassessment, that documentation will take longer to prepare than expected, that internal resources will face competing priorities, and that notified body capacity will be constrained as deadlines approach. Organizations planning to be market-ready by August 2026 should aim to begin formal assessment by early 2026 at the latest, which means preparation should be well underway now.

Understanding and Managing Costs

Conformity assessment represents a significant investment, but understanding cost drivers helps you budget effectively and potentially reduce expenses through good preparation. Costs vary widely based on system complexity, assessment scope, and organizational readiness.

Notified body fees typically include application and contract establishment, documentary review and assessment, technical evaluation and testing if required, certification and administrative costs, and annual surveillance activities. Total initial assessment costs generally range from €50,000 to €200,000 ($55,000 to $220,000 USD) for complex AI systems, with annual surveillance adding €10,000 to €30,000 ($11,000 to $33,000 USD). These are indicative ranges—actual costs depend on numerous factors.

Several factors influence assessment costs. System complexity is paramount—a straightforward AI system with limited functionality costs less to assess than a complex, adaptive system. The quality and completeness of your documentation significantly impacts review time and cost. Organizations with mature quality systems and prior certification experience often see lower costs due to efficient processes. The assessment module chosen also affects cost, with self-assessment being less expensive but requiring strong internal capabilities.

Beyond notified body fees, budget for internal costs including staff time for preparation and assessment support, potential consultant fees for gap analysis or remediation, testing and validation to demonstrate compliance, documentation development and management systems, and ongoing compliance maintenance. Many organizations find that internal costs exceed external fees, particularly for their first AI system assessment.

Strategies for Cost Optimization

While conformity assessment is necessarily rigorous, several strategies can help optimize costs without compromising compliance quality. These approaches require planning and discipline but can yield significant savings.

Preparation is the most effective cost reduction strategy. Organizations that approach assessment with complete documentation, addressed gaps, trained personnel, and established processes typically see 30-50% lower assessment costs than those who iterate during assessment. Invest in thorough preparation even if it means higher upfront costs—it pays dividends during assessment.

Consider shared assessments for similar systems. If you're developing multiple AI systems with common architectures or components, structure them to maximize assessment efficiency. This might involve common quality management systems, shared technical documentation frameworks, modular assessment approaches, and combined surveillance activities. Discuss these opportunities with your notified body during planning.

Learn from others' experiences. Industry associations, regulatory sandboxes, and peer networks provide valuable insights into assessment best practices. Understanding common pitfalls helps you avoid costly mistakes. Some member states offer support programs for SMEs that can reduce both cost and risk. Don't hesitate to seek guidance from organizations that have successfully completed assessment.

Common Challenges and How to Address Them

Documentation Challenges

The most common challenge organizations face is developing technical documentation that meets AI Act requirements. The Act demands comprehensive documentation that serves multiple audiences—regulators, notified bodies, and potentially users—while remaining accurate and maintainable.

Many organizations underestimate documentation scope, thinking existing development documentation will suffice. However, AI Act documentation must explicitly address regulatory requirements, explain decisions and trade-offs, demonstrate risk assessment and mitigation, and remain understandable to non-specialists. This often requires significant rework of existing materials or creation of new regulatory-focused documentation.

Address documentation challenges by starting early and maintaining documentation throughout development. Assign clear ownership for documentation components, establish templates and standards for consistency, implement review processes for accuracy and completeness, and use documentation management systems for version control. Consider that documentation isn't just for compliance—good documentation improves system quality and team knowledge.

Technical Assessment Complexities

AI systems present unique assessment challenges compared to traditional products. Their probabilistic nature, data dependencies, and potential for post-deployment learning create complexities that both organizations and notified bodies are still learning to address.

Performance validation is particularly challenging. How do you prove that an AI system will perform safely and effectively across all intended use cases? This requires comprehensive test datasets that represent real-world diversity, validation methodologies that address edge cases, metrics that meaningfully measure performance and safety, and evidence that performance will be maintained over time. Many organizations struggle to develop validation approaches that satisfy assessment requirements while remaining practical.

Address technical complexities through systematic approach to validation and testing. Develop clear performance requirements linked to intended use, create comprehensive test strategies covering normal and edge cases, maintain detailed records of all testing activities, and establish post-market monitoring to verify ongoing performance. Engage with your notified body early to align on validation approaches—they can provide valuable guidance on what evidence will be sufficient.

Managing Stakeholder Expectations

Conformity assessment affects multiple stakeholders—management, development teams, customers, and investors—each with different concerns and expectations. Managing these diverse perspectives while maintaining focus on compliance can be challenging.

Leadership may underestimate the time and resources required for assessment, expecting a quick checkbox exercise rather than comprehensive evaluation. Development teams may resist documentation requirements or view assessment as bureaucratic interference. Customers may not understand why products are delayed for certification. Investors might question the return on compliance investment.

Manage expectations through clear, consistent communication about assessment requirements, timelines, and benefits. Develop a stakeholder communication plan that provides regular updates on assessment progress, explains how compliance creates competitive advantage, addresses concerns proactively, and celebrates compliance milestones. Frame assessment not as a regulatory burden but as validation of your AI system's trustworthiness and market readiness.

Looking Ahead: The Evolution of the Notified Body Ecosystem

Building Capacity for August 2026

As we progress through late 2025, the notified body ecosystem is rapidly evolving to meet expected demand. Current estimates suggest that hundreds of high-risk AI systems will require assessment before August 2026, creating significant capacity challenges that the ecosystem is working to address.

Several developments are helping build capacity. More organizations are seeking designation as notified bodies, existing bodies are expanding their AI expertise through hiring and training, collaboration agreements are enabling resource sharing, and standardized assessment methodologies are improving efficiency. However, capacity constraints remain a real concern, particularly for specialized domains requiring specific expertise.

Organizations can help address capacity challenges while serving their own interests. Engage with notified bodies early to help them plan resource allocation. Provide feedback on assessment processes to improve efficiency. Share experiences with peers to build collective knowledge. Support development of harmonized standards that enable self-assessment. Remember that a mature, efficient notified body ecosystem benefits everyone developing AI systems.

Harmonization and Standardization Efforts

The effectiveness of the notified body system depends on consistent assessment approaches across different bodies and member states. Significant efforts are underway to harmonize assessment methodologies and develop supporting standards.

The European Commission and standardization bodies are developing harmonized standards for AI systems, common assessment methodologies and best practices, guidance documents for specific sectors and use cases, and mutual recognition agreements to facilitate international trade. These efforts aim to create predictability and consistency while maintaining flexibility for innovation. As standards emerge, they'll provide clearer pathways to compliance and potentially enable more self-assessment options.

Stay informed about standardization efforts in your domain. Participate in standards development if possible—industry input is crucial for practical standards. Monitor draft standards and provide feedback during consultation periods. Early adoption of emerging standards can provide competitive advantage and smoother assessment. Your notified body can often provide insights into forthcoming standards and their implications.

International Cooperation and Recognition

The EU AI Act doesn't exist in isolation—it's part of a global movement toward AI regulation. International cooperation on conformity assessment is emerging, potentially simplifying compliance for organizations operating globally.

Discussions are underway regarding mutual recognition agreements with other jurisdictions, common assessment frameworks for international organizations, coordination between different regulatory regimes, and shared learning between assessment bodies globally. While full mutual recognition remains distant, incremental progress is being made on specific aspects like testing methodologies and documentation standards.

Consider international dimensions when selecting notified bodies and planning assessment. Bodies with international experience and connections may provide advantages for global market access. Documentation developed for EU assessment might support compliance elsewhere with modest additions. Assessment findings might influence product development for other markets. Think globally even while focusing on EU compliance.

Conclusion: Embracing Notified Bodies as Compliance Partners

As we stand in September 2025, with the August 2026 deadline approaching but still manageable, the role of notified bodies in AI Act compliance is becoming increasingly clear. These organizations aren't bureaucratic gatekeepers designed to impede innovation—they're expert partners equipped to help ensure that AI systems meet the high standards necessary for trustworthy AI.

The key to successful engagement with notified bodies lies in preparation, transparency, and viewing assessment as valuable validation rather than regulatory burden. Organizations that embrace this perspective typically find assessment less daunting than anticipated and more valuable than expected. The insights gained through assessment often improve not just compliance but overall system quality and market readiness.

Remember that everyone—regulators, notified bodies, and the AI industry—shares the same goal: enabling beneficial AI innovation while protecting fundamental rights and safety. Notified bodies exist to verify that this balance is achieved, providing the independent validation that builds trust in AI systems. By understanding their role and working with them effectively, you're not just achieving compliance—you're contributing to the responsible development of AI in Europe.

The journey through conformity assessment may seem complex, but you don't have to navigate it alone. Notified bodies, industry associations, regulatory authorities, and peer organizations all provide support and guidance. Start your preparation now, engage with the ecosystem early, and approach assessment with confidence. The organizations that master conformity assessment today will be the AI leaders of tomorrow, trusted by regulators, customers, and society to deliver the benefits of AI while managing its risks.

The path forward is clear: understand your requirements, select the right notified body, prepare thoroughly, and engage transparently. With these steps, conformity assessment becomes not an obstacle to overcome but a milestone to achieve on your journey toward trustworthy, compliant, and successful AI deployment in the European market.