Does the Cyber Resilience Act Apply to Healthtech Apps?
Learn if the EU CRA applies to Healthtech Apps, what the core compliance requirements are, and how to start preparing your engineering teams automatically.
Core Definition
Yes. The EU Cyber Resilience Act applies directly to Healthtech Apps as they fall under the definition of "products with digital elements." A symptom-checker app not classified as a medical device under the MDR is squarely in CRA scope even though it handles health data. This means your software must meet mandatory cybersecurity requirements to be distributed in the EU market.
Key Compliance Steps for Healthtech Apps
- Determine Classification: Check if your Healthtech Apps falls under the default category or Class I/Class II, which dictate stricter conformity assessment paths.
- Perform Risk Assessment: Map out the attack surface for your software and document the mitigations for the "secure by design" requirement.
- Implement Vulnerability Reporting: Provide a 24-hour reporting mechanism to ENISA for actively exploited vulnerabilities.
- Generate an SBOM: Ensure all dependencies used in your Healthtech Apps are documented in a machine-readable Software Bill of Materials.
- Avoid the Common Pitfall: Assuming any app touching health data automatically falls under MDR — most consumer wellness apps don't.
How This Plays Out in Practice
A symptom-checker app not classified as a medical device under the MDR is squarely in CRA scope even though it handles health data.
What to Watch For
Assuming any app touching health data automatically falls under MDR — most consumer wellness apps don't.
Assess Your CRA Readiness
Evaluate your product's Cyber Resilience Act readiness using our interactive tool. Find exactly which of the 22 security requirements apply directly to Healthtech Apps.