The Tandem Health medical scribe has been certified under the European Medical Devices Regulation (MDR) as a Class IIa medical device, after passing review by an independent Notified Body and a formal conformity assessment. This makes Tandem the first medical scribe in Europe to achieve this classification.
This adds to its coding assistant, which obtained Class IIa certification in February 2026. Tandem already serves more than 5,000 healthcare organizations across Europe and is integrated with more than 100 European electronic health record (EHR) systems.
Under the European Medical Devices Regulation, products that generate clinical information capable of influencing patient care are classified as Class IIa. Unlike Class I devices, whose evaluation is conducted by the manufacturer, Class IIa requires an independent Notified Body to audit the technical, clinical, and AI‑specific evidence backing the product. The Tandem medical scribe falls into this classification because it summarizes the consultation into a medical note that is transferred directly into the patient’s EHR, forming the basis for future clinical decisions related to that patient.
The NHS and the Swedish Medical Products Agency consider AI‑based documentation assistants to be medical devices, and therefore require CE certification under the MDR prior to clinical deployment. For healthcare organizations, this provides independent assurance of the product’s clinical performance and safety. The regulatory position is clear: procurement, legal, and information governance reviews can move more quickly because the underlying work has already been completed. (For American readers: in the United States, the analogous regulatory pathway for many Class II devices is FDA clearance, typically through the 510(k) process.)
Together, the medical scribe and the coding assistant form a regulated platform that covers the entire clinical documentation workflow: from real-time note generation during the consultation to the subsequent structured coding of diagnoses and procedures, all under a unified MDR posture in the EU and the UK.
“We are building Tandem to become the gold standard for clinical AI in Europe. The Class IIa certification for the medical scribe is new proof of that. Two certified products, one regulated platform, designed for the world’s most demanding healthcare environments. This is how European clinical AI is built.”
