Medical Device Certification
Current portfolio of regulatory approvals
Certification timeline
Quality management system: ISO 13485
Legit.Health operates a fully certified quality management system under ISO 13485:2016, certified by BSI (certificate number MD 792784, issued August 2024, valid until August 2027).
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 IIb under Rule 11 (software providing information used to take decisions with diagnosis or therapeutic purposes). Class IIb sits above the typical software classification, reflecting the clinical depth of our intended use.
Status: Transition in progress with notified body BSI. Consulting partner PS Consulting (Madrid). Expected completion of full MDR Class IIb certification: 2026.
What the MDR Class IIb step-up unlocks commercially
MDD keeps the platform fully operational across the EU today. Completing MDR Class IIb is the appropriate classification for a multi-condition decision-support platform: a credibility and future-proofing step, not a catch-up.
- Clinical-grade credibility. Class I is self-certified; Class IIb is audited by a Notified Body (BSI) against the clinical depth of the intended use. Completing it moves the platform from self-certified to clinical-grade for hospitals, insurers and pharma.
- Procurement future-proofing. MDD legacy devices remain valid on the EU market until 2027-2028; MDR Class IIb (on track with BSI) removes any future procurement objection and protects the pipeline well before the deadline.
- The right class for our intended use, by design. Class IIb (Rule 11) covers decision support with diagnostic or therapeutic purpose, with the clinician in the loop, across 300+ conditions. That is a deliberate positioning, distinct from a single-purpose autonomous device (a higher class covering one use case). Breadth of clinical coverage, not the class number, is the hard part, and where the platform leads.
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.