EU Compliance for Healthcare & MedTech
EU regulations directly affecting Healthcare & MedTech organisations — including obligations, deadlines, and maximum fines. Use our regulation checker to map your exact exposure.
Which EU regulations apply to Healthcare & MedTech businesses?
Healthcare & MedTech organisations operating in the EU are subject to 4 key regulations, including AI Act, NIS2, Pay Transparency and 1 more. The most significant obligations cover Classify AI systems by risk tier; Implement cybersecurity risk management measures. Use the regulation checker to map your exact exposure in under 2 minutes.
- AI Act: max fine €35M or 7% of global turnover — Classify AI systems by risk tier
- NIS2: max fine €10M or 2% of global turnover — Implement cybersecurity risk management measures
- Pay Transparency: max fine Per member state (compensation + penalties) — Publish salary ranges in job adverts
- eIDAS 2.0: max fine Per member state — Accept EU Digital Identity Wallet (very large platforms)
| Regulations applicable | 4 |
| Key regulations | AI Act, NIS2, Pay Transparency |
| Highest fine | €35M or 7% of global turnover |
Regulations that apply to Healthcare & MedTech
AI Act
The EU AI Act classifies AI systems by risk level and imposes obligations on providers and deployers. High-risk systems face mandatory conformity assessments, documentation, and human oversight requirements.
Max fine: €35M or 7% of global turnover
NIS2
NIS2 expands cybersecurity obligations to essential and important entities across critical sectors. It mandates risk management, incident reporting, and supply chain security.
Max fine: €10M or 2% of global turnover
Pay Transparency
The Pay Transparency Directive requires employers to disclose salary ranges in job postings, report on gender pay gaps, and enable employees to compare pay. Targets the gender pay gap across the EU.
Max fine: Per member state (compensation + penalties)
eIDAS 2.0
eIDAS 2.0 updates the framework for electronic identification and trust services, introducing the EU Digital Identity Wallet. It enables cross-border digital identity verification and expands recognised trust services.
Max fine: Per member state
Which regulations apply to your Healthcare & MedTech business?
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- EU AI Act
- General Data Protection Regulation
- NIS2 Directive
- Cyber Resilience Act
- Digital Operational Resilience Act
- EU Data Act
- European Accessibility Act
- ePrivacy Directive
- Digital Services Act
- Digital Markets Act
- Pay Transparency Directive
- Whistleblower Directive
- Markets in Crypto-Assets Regulation
- eIDAS 2.0 Regulation
- Product Liability Directive (Revised)
- Corporate Sustainability Reporting Directive
- Corporate Sustainability Due Diligence Directive
- Green Claims Directive
- European Accessibility Act
- EU Machinery Regulation
For informational purposes only. This is not legal advice — consult qualified legal counsel.