EU AI Act (European Union Artificial Intelligence Act) || Tacit MedTek

INFORMATION SECURITY & PRIVACY

Quick Snapshot

Service / Form – EU AI Act Consultancy & Compliance Support
Who Can Apply – AI Developers, Software Companies, Healthcare Organizations, Medical Device Manufacturers, Startups, Importers & Distributors
Timeline – 3-9 months

What is EU AI Act (European Union Artificial Intelligence Act)?

The EU AI Act is the world’s first law regulating artificial intelligence, aimed at ensuring AI is safe, fair, and trustworthy for everyone. It categorizes AI systems into four risk levels:

Unacceptable risk: Banned AI applications, such as social scoring
High risk: Subject to strict safety and compliance rules, such as AI used in hiring or healthcare
Limited risk: Must be clearly labelled, such as chatbots
Minimal risk: No specific rules, such as AI in games

Companies violating these rules can face fines up to €35 million or 7% of their global turnover. The Act guarantees AI respects people’s rights and promotes trustworthiness.

When Do You Need EU AI Act Compliance Support?

Practical support for organizations developing, deploying, or selling AI systems in Europe, with a focus on risk classification, governance, documentation, transparency, and ongoing compliance.

When Do You Need EU AI Act Support?

Developing AI software or AI-based products
Using AI in healthcare, HR, finance, or education
Selling AI products in the European market
Using chatbots or generative AI tools
Needing AI governance and risk-management systems
Preparing for EU regulatory requirements

Key Challenges

Understanding AI risk classification
Preparing required technical and compliance documentation
Managing AI risks and data governance
Meeting transparency and cybersecurity requirements
Maintaining ongoing compliance

Our Approach and What You Will Get

Structured support for assessing AI systems under the EU AI Act, establishing governance and data controls, and preparing compliance documentation.

Our Approach

EU AI Act gap assessment and applicability review
AI system inventory and classification
Fundamental Rights Impact Assessment (FRIA) support
Human oversight assessment
Data governance and quality review
Post-market monitoring planning

What You Will Get (Deliverables)

AI system classification report
AI governance framework
Post-market monitoring plan
Human oversight procedure
Data governance procedure
Technical file / Annex IV documentation support
EU AI Act gap assessment report

Why Choose Tacit Medtek and Case Example

Practical, end-to-end support for AI and medical device companies preparing for EU AI Act compliance, governance documentation, and European market readiness.

Why Choose Tacit Medtek?

Regulatory compliance expertise
Practical and customized solutions
Support for AI and medical device companies
End-to-end documentation assistance
Alignment with the EU AI Act and ISO standards
End-to-end support from initial gap assessment through technical documentation and audit readiness

Case Example

Challenge: A healthcare software company developing an AI-powered clinical decision-support tool needed to determine whether its product qualified as a High-Risk AI system under the EU AI Act and what compliance steps were required before entering the European market.
Our Approach: Conducted an EU AI Act applicability review and risk-classification assessment; determined High-Risk AI classification and applicable Annex III obligations; performed a gap assessment against EU AI Act technical documentation requirements; developed an AI Governance Framework and Human Oversight Procedure; and prepared Annex IV Technical Documentation and a post-market monitoring plan.
Outcome: The company achieved a structured compliance roadmap and submission-ready AI governance documentation within a few months, enabling confident entry into the European market.

FAQ

Frequently Asked Questions

Who needs to comply with the EU AI Act?

Any company developing, selling, importing, or using AI systems in the European market may need to comply with the EU AI Act requirements.

What are High-Risk AI systems?

AI systems used in healthcare, medical devices, recruitment, education, banking, and other critical sectors are generally considered High-Risk AI systems.

What happens if a company does not comply?

Non-compliance can result in heavy penalties, legal action, market restrictions, and reputational risks.

Is the EU AI Act applicable to startups?

Yes. Startups developing or using AI systems for the EU market may also need to comply with the regulation.

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