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GDPREU DataSOC 2 Type IIISO 27001
🇪🇺European Union

Medical Devices compliance in the EU

Navigate the regulatory landscape for medical devices companies operating in the EU. Cleo maps applicable frameworks and monitors enforcement in real time.

Start free scan
Anaelle GuezNaomie Halioua
or book a call

Applicable regulations

Key frameworks that medical devices companies must comply with in the EU.

MDR 2017/745
IVDR 2017/746
EUDAMED
ISO 13485
GDPR
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

One platform for every market

Product Compliance

Map the regulations your medical devices product must comply with to launch or operate in the EU.

Learn more

Related pages

All regulations in the EU|Medical Devices compliance overview| GDPR in the EU| EU AI Act in the EU| DORA in the EU| CSRD in the EU

Medical Devices compliance in other jurisdictions

🇫🇷France🇩🇪Germany🇬🇧United Kingdom🇺🇸United States🇧🇷Brazil🇦🇺Australia🇮🇳India

Ready to automate medical devices compliance in the EU?

Start free scan
Anaelle GuezNaomie Halioua
or book a call