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AI-powered regulatory intelligence.

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  • Due Diligence
  • Product Compliance

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Jurisdictions

  • ๐Ÿ‡ช๐Ÿ‡บ European Union
  • ๐Ÿ‡ซ๐Ÿ‡ท France
  • ๐Ÿ‡ฉ๐Ÿ‡ช Germany
  • ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom
  • ๐Ÿ‡บ๐Ÿ‡ธ United States

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Events

  • VivaTech ParisJun 11โ€“14, 2026

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GDPREU Data
๐Ÿ‡ช๐Ÿ‡บEuropean Union

HealthTech compliance in European Union

Navigate the regulatory landscape for healthtech companies operating in European Union. Cleo maps applicable frameworks and monitors enforcement in real time.

Run a Free Scan
Anaelle GuezNaomie Halioua
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Applicable regulations

Key frameworks that healthtech companies must comply with in European Union.

GDPR
MDR
IVDR
EHDS
AI Act
NIS2

How Cleo helps

Your compliance roadmap, automated by AI.

1Identify all applicable regulations for your products and markets
2Map your obligations and deadlines with AI-powered analysis
3Screen third parties and suppliers for regulatory risk
4Generate audit-ready compliance reports with full traceability
5Monitor regulatory changes and receive real-time alerts

Two solutions, one platform

Third-Party Due Diligence

Screen partners and suppliers operating in European Union against sanctions, adverse media, and regulatory databases.

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Product Compliance

Map the regulations your healthtech product must comply with to launch or operate in European Union.

Learn more

Related pages

All regulations in European Union|HealthTech compliance overview| GDPR in European Union| EU AI Act in European Union| DORA in European Union| CSRD in European Union

HealthTech compliance in other jurisdictions

๐Ÿ‡ซ๐Ÿ‡ทFrance๐Ÿ‡ฉ๐Ÿ‡ชGermany๐Ÿ‡ฌ๐Ÿ‡งUnited Kingdom๐Ÿ‡บ๐Ÿ‡ธUnited States๐Ÿ‡ง๐Ÿ‡ทBrazil๐Ÿ‡ฆ๐Ÿ‡บAustralia๐Ÿ‡ฎ๐Ÿ‡ณIndia

Ready to automate healthtech compliance in European Union?

Run a Free Scan
Anaelle GuezNaomie Halioua
or book a call