ServicesEU AI Act + MDR / IVDR

EU AI Act, MDR and IVDR regulatory strategy

Companies developing AI-enabled medical devices in Europe may need to comply with more than one regulatory framework. The practical challenge is not understanding each regulation in isolation. It is understanding what the combined system requires from the same product, quality system and technical documentation.

Fabola maps how the EU Artificial Intelligence Act interacts with the MDR or IVDR and identifies what can be integrated into the existing medical-device compliance system, what is genuinely additional and which obligations need dedicated implementation.

Who this is for

  • AI-enabled medical device manufacturers
  • AI-enabled IVD manufacturers
  • Medical device software developers
  • HealthTech companies moving into regulated medical use
  • Manufacturers adding AI functionality to an existing product
  • Non-European AI companies entering the EU market

The problem it solves

  • Does the EU AI Act apply to our system?
  • Is our AI system in a high-risk category?
  • Who is the provider under the AI Act?
  • How does AI Act risk management interact with medical-device risk management?
  • Can existing MDR or IVDR documentation support AI Act obligations?
  • What additional documentation is required?
  • How should data governance be documented?
  • How do human-oversight requirements apply?
  • How should post-market monitoring be integrated?

Required inputs

  • Intended purpose
  • Device classification
  • Conformity assessment route
  • AI architecture and functionality
  • Intended users
  • QMS structure
  • Risk-management documentation
  • Software and AI lifecycle processes
  • Current technical documentation where available

What Fabola does

We analyse whether and how the AI Act applies, including the high-risk pathway where relevant, and map where it overlaps with the MDR or IVDR.

We set out who owns each requirement and what it means for documentation and the product lifecycle, then identify the evidence and process gaps and the priorities for implementation.

Deliverables

  • AI Act + MDR/IVDR Regulatory Map
  • Applicability assessment
  • High-risk analysis where relevant
  • Overlap matrix
  • Gap analysis
  • Documentation recommendations
  • Responsibility matrix
  • Prioritised implementation plan

Price

Focused applicability map

SEK 39,000

Determines whether and how the AI Act applies and identifies the main interaction with the existing MDR or IVDR pathway.

Integrated assessment

SEK 49,000

Typical one-product assessment covering applicability, overlap, gap map, responsibilities and implementation priorities.

Complex integrated assessment

SEK 69,000–79,000

Multiple AI functions, complex provider/deployer relationships, multiple product configurations or substantial implementation mapping.

All prices are in SEK and exclude VAT.

Delivery time

Typical delivery: 10–15 business days.

Completion point

The project is complete when the company has a documented view of which obligations apply, how they interact with MDR or IVDR compliance and what needs to be implemented next.

Exclusions

  • Formal legal opinion
  • Contractual or liability advice
  • GDPR or privacy legal advice
  • Full implementation of the identified QMS or technical-documentation changes

If further work is needed

Depending on the outcome, no further Fabola work may be required. Where additional work is identified, common next steps include implementation of the identified requirements, an AI validation and evidence assignment, or a targeted MDR / IVDR readiness review.

Frequently asked questions

Does the EU AI Act apply to medical devices?

It can. The AI Act includes a high-risk route for certain AI systems that are products, or safety components of products, covered by EU product legislation and subject to third-party conformity assessment. The product-specific analysis must consider the relevant AI Act provisions together with the MDR or IVDR pathway.

Do we need a separate AI compliance system?

Not necessarily. Many governance, risk, quality, documentation and post-market activities can be mapped against existing medical-device processes. The assessment identifies where integration is appropriate and where the AI Act creates additional obligations.

Is every AI-enabled medical device automatically high-risk under the AI Act?

No. The classification needs to be analysed against the AI Act criteria and the product’s applicable conformity assessment route. The answer should be documented rather than assumed.

Can this be done before our MDR or IVDR technical file is complete?

Yes. An early integrated assessment can help avoid building separate processes that later need to be reconciled.

Primary regulatory sources

Last reviewed: September 2026

Related services

AI validation and evidence

How do we demonstrate that our AI-enabled medical device works reliably and safely for its intended medical use?

MDR and IVDR readiness

How far are we from being ready for CE marking under the MDR or IVDR?

Classification and conformity pathway

Is my product a medical device or IVD, what class is it, and what do I need to do to place it on the EU market?

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Ready to define the work?

Tell us what the product is, where the project stands and the regulatory question you need answered.

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