Medical Device Certification
Current portfolio of regulatory approvals
Certification timeline
Complementary certification: ENS Alto (Spain)
In addition to the medical device certifications above, Legit.Health holds ENS (Esquema Nacional de Seguridad) at the "Alto" level, the highest tier of Spain's national security framework for information systems.
Most early-stage healthtech startups don't hold ENS Alto because the certification process is intense (full information security management system, CCN audit, multi-month effort). Holding it pre-Series A unlocks immediately the Spanish public administration procurement channel that competitors without certification cannot access. SESPA (Asturias) was the first deal closed leveraging this enabler.
EU MDR transition
The MDR (Medical Device Regulation 2017/745) imposes stricter requirements than the previous MDD. Under MDR, our solution is classified as Class IIa (intended for diagnosis support and severity measurement).
Status: Transition in progress with notified body BSI. Consulting partner PS Consulting (Madrid). Expected completion of full MDR Class IIa certification: 2026.
Intended use
Legit.Health is a clinical decision support system intended for use by healthcare professionals (dermatologists, general practitioners, nurses, and other licensed clinical staff). It provides:
- Diagnosis support: differential diagnosis for 300+ dermatological conditions
- Severity measurement: automated scoring on validated scales (PASI, SCORAD, IHS4, AUAS, SALT, GPPGA, AGPPGA)
- Image quality assurance (DIQA): filtering of non-diagnostic images, enabling teleconsultation at clinical quality
Patients can access the device only when the care provider has granted them access. Direct-to-patient use is not within the intended use.