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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‡ฉ๐Ÿ‡ชGermany

HealthTech compliance in Germany

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

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Anaelle GuezNaomie Halioua
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Applicable regulations

Key frameworks that healthtech companies must comply with in Germany.

GDPR/BDSG
DiGA (Digital Health Apps)
MDR/IVDR
SGB V

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 Germany 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 Germany.

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Related pages

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

HealthTech compliance in other jurisdictions

๐Ÿ‡ช๐Ÿ‡บEuropean Union๐Ÿ‡ซ๐Ÿ‡ทFrance๐Ÿ‡ฌ๐Ÿ‡งUnited Kingdom๐Ÿ‡บ๐Ÿ‡ธUnited States๐Ÿ‡ง๐Ÿ‡ทBrazil๐Ÿ‡ฆ๐Ÿ‡บAustralia๐Ÿ‡ฎ๐Ÿ‡ณIndia

Ready to automate healthtech compliance in Germany?

Run a Free Scan
Anaelle GuezNaomie Halioua
or book a call