Europe’s regulatory technology market is entering a new phase. From 2 August 2026, the European Commission’s AI Office and national authorities began exercising enforcement powers under the EU AI Act, while transparency obligations for certain AI systems also became applicable.
The rollout remains phased, with some rules governing high-risk systems will not apply until 2027 or 2028, but the direction of travel is clear: companies deploying AI are facing greater expectations around documentation, transparency, security, traceability and human oversight.
That shift is creating opportunities for a new generation of European startups working across AI governance, regulatory intelligence, auditability, security and highly regulated industries.
Not every company below is an AI Act compliance vendor in the narrow sense. Some address adjacent regulatory problems in healthcare, tax, auditing and business resilience, where the same demand for verifiable and defensible technology is becoming increasingly important.
Here are 10 European compliance startups to keep an eye on, presented in alphabetical order.
Biorce
Launched in Barcelona in 2024, Biorce is applying AI to one of the most heavily regulated areas of healthcare: clinical trials. Its platform, Aika, supports processes including protocol design, feasibility assessment and regulatory planning, with the aim of making trial preparation faster while retaining the documentation and reasoning needed for regulatory scrutiny.
That makes Biorce a somewhat broader compliance play than a dedicated AI governance platform, but a relevant one. Healthcare organisations adopting AI must balance automation with scientific rigour, documentation and human decision-making, and Biorce is building directly within that environment.
The startup has also scaled quickly. In February, the company closed a €43.8 million Series A to accelerate its AI-driven clinical-trials platform and international expansion.
CertHub
Munich-based CertHub was founded in 2024 to tackle the paperwork-heavy regulatory burden facing medical-device manufacturers. Its AI-first compliance platform automates areas including technical documentation, quality-management workflows, conformity assessments and audit preparation.
The company is primarily focused on requirements such as the EU’s Medical Device Regulation and In Vitro Diagnostic Regulation rather than the AI Act itself.
Nevertheless, the overlap is significant: as AI becomes embedded in medical products and their development processes, healthcare companies increasingly have to navigate several regulatory frameworks simultaneously.
Cleo Labs
Paris has been home to Cleo Labs since its founding in 2023. The RegTech startup is developing an AI-powered platform for international product compliance, helping companies determine which regulations apply before launching products and then monitor regulatory changes across markets.
Its proprietary multi-agent system, MARIA, continuously tracks regulatory sources and converts changing rules into more manageable compliance workflows. Legal experts remain in the loop to validate its analyses, an approach that is particularly relevant as businesses become more cautious about relying on opaque AI outputs for regulatory decisions.
In April 2026, Cleo Labs raised €1.5 million in funding, noting that its platform monitors more than 25,000 regulatory authorities across 106 countries.
Cortea
Founded in 2024, Berlin’s Cortea is building AI specifically for the audit profession. Its Audit Quality Agents review financial statements, reports, disclosures and supporting workpapers, helping firms detect inconsistencies and potential compliance issues before sign-off.
The proposition becomes particularly relevant as auditors themselves begin incorporating generative and agentic AI into professional workflows. Faster output alone is not enough in audit: work still has to be reviewable, defensible and aligned with professional standards. Cortea is positioning its technology as the quality-control layer between AI-driven efficiency and those obligations.
Copenhagen is the base for Fortiv, a startup founded in 2025 around AI-native business continuity management. Its platform uses AI agents to collect business-impact information, interpret regulatory requirements and help organisations construct and maintain compliant continuity frameworks.
Fortiv sits at the intersection of compliance and operational resilience rather than focusing solely on AI regulation. That makes it relevant to companies facing overlapping requirements around cyber resilience, continuity, risk management and increasingly governed AI deployments.
Founded in Stockholm in 2023, Hybridity is one of the clearest RegTech plays on this list. Its AI-native Hy5 platform is designed to automate regulatory work for organisations operating under complex European requirements, including DORA, NIS2 and GDPR.
Rather than treating compliance as a periodic exercise, Hybridity wants organisations to manage requirements continuously. Its technology combines AI with legal engineering to help interpret regulations, assign responsibilities, conduct analyses and maintain traceability – a model that could become increasingly valuable as businesses have to demonstrate not merely that policies exist, but how regulatory obligations are being implemented.
In February, Hybridity raised €2 million, bringing total funding reported at the time to around €5 million.
NeuralTrust
Established in Barcelona in 2022, NeuralTrust is building a security and governance layer for enterprise AI agents. Its platform gives companies visibility over deployed agents and the models, tools and systems they interact with, while enforcing security and policy controls around their behaviour.
The rise of autonomous agents makes that proposition increasingly important. Once AI can interact with internal databases, applications and external services — and potentially take actions rather than simply generate text — enterprises need mechanisms for discovering those agents, monitoring activity and controlling what each system is allowed to do.
NeuralTrust raised a €17.2 million Seed round this summer, which they described as which the company described as the largest cybersecurity Seed financing raised by an EU company at that time.
Outpost
London-based Outpost was founded in 2024 and tackles compliance from a different direction: cross-border commerce.
The startup provides infrastructure for payments, tax and regulatory obligations, effectively taking on parts of the legal and administrative burden that merchants would otherwise face when entering new markets.
Its Tax of Record product assumes responsibility for VAT, GST and sales-tax obligations, while Outpost AI monitors regulatory developments. The company therefore shows how AI-enabled compliance is expanding well beyond dedicated governance dashboards and into the underlying infrastructure businesses use to transact internationally.
In March of this year, Outpost raised €15 million in funding, highlighting its model of absorbing audit risk and handling regulatory changes for merchants.
Rippletide
Founded in 2024, Paris-based Rippletide is focused on solving the problem of making enterprise AI agents more predictable, explainable and auditable. Instead of allowing an LLM to determine every aspect of an agent’s decision-making, the startup is developing infrastructure that places explicit evidence and decision rules around high-risk actions.
Its current product focuses on areas such as decision previews, evidence-linked reasoning and traceability. For compliance teams, that distinction matters: knowing that an AI agent performed an action is different from being able to establish which evidence, policy and rule justified it.
Rulemapping Group
Operating from Berlin since 2024, Rulemapping Group is approaching compliance at the level of the rules themselves. Its technology converts laws and regulations into structured, machine-readable decision logic that can be used to automate complex administrative and legal processes.
The idea is particularly relevant to regulated AI because one of the central difficulties in compliance is translating lengthy, interconnected legal texts into rules software can reliably execute.
Rulemapping’s “law as code” approach is designed to make conditions, exceptions and legal dependencies explicit rather than relying solely on an LLM to interpret them each time a decision is required.
Summary
With enforcement machinery now active, Europe’s AI regulation is moving from preparation to implementation. The startups positioned to benefit will not necessarily be those promising a single “AI Act compliant” badge.
The bigger opportunity may lie with companies that make governance operational: turning rules into workflows, producing evidence, securing autonomous systems, maintaining human oversight and giving organisations an auditable record of how automated decisions were reached.
For Europe’s compliance startups, that makes the next phase of the AI Act as much a software-infrastructure opportunity as a legal one.
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CertHub
CertHub
Cleo Labs
Cortea
Fortiv
NeuralTrust
Rippletide
Rulemapping Group
