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5.1 Is Ada a medical device?

In Europe, Ada's enterprise product available to clients called 'Ada Assess' is CE-certified as a Class IIa medical device in the EU according to Regulation (EU) 2017/745 (EU-MDR). This includes the following modules:

  • Ada's Medical Platform (the means of accessing Ada's medical content)
  • Assess (symptom assessment)
  • Connect (care navigation)
  • Handover (sharing assessment reports with clients)
  • FHIR services (interoperability with partner systems)
  • Smart Auth (identification management and SSO

Ada's Quality Management System is also certified under ISO 13485.

In the UK, Ada Assess enterprise product is UK Conformity Assessed (UKCA) and registered with the Medicines and Healthcare products Regulatory Agency (MHRA).

Ada's consumer app is currently a Class I medical device (EU-MDR Class IIa pending).

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