The audit by Notified Body ECM (NB 1282) covers, for the first time, the artificial intelligence components of the telemonitoring system, already in use at more than 30 hospitals.

vitalera, provider of an AI-powered remote patient monitoring (RPM) solution, has obtained Class IIb medical device certification under the European Medical Device Regulation (MDR, EU 2017/745), following a full audit by Notified Body ECM (NB 1282). The process assessed the complete software lifecycle, clinical evidence, cybersecurity and the artificial intelligence components of the platform — including AI-powered scanning of readings from any type of medical device — and certified the company's quality management system under ISO 13485:2016

With this CE marking, vitalera becomes one of the first remote patient monitoring and telemonitoring platforms in Europe to certify AI functionality under the MDR, regarded as the most demanding regulatory framework applied to date to software as a medical device (SaMD) in Europe, with its AI-based image-scanning system for any device.

A comprehensive audit process

Class IIb certification means an independent notified body has validated the product's own clinical evidence; its risk management, including cybersecurity and cloud infrastructure; the verification and validation of the AI components under the same standards as the rest of the software; and its post-market surveillance system, which requires the company to continuously monitor and report on the product once it is on the market.

This classification sets vitalera apart from other telemonitoring and virtual care platforms holding lower-class certifications. For hospitals, national health systems, insurers and pharmaceutical companies, the certification streamlines the deployment of remote care, hospital-at-home and virtual ward programmes, and opens access to public tenders and clinical studies across Europe that require MDR compliance.

What the certified platform covers

The certified product integrates multimodal patient monitoring — connected medical devices (blood pressure monitors, pulse oximeters, scales, etc.), wearables, smart patient-reported outcome measures (PROMs) questionnaires and clinical data — into a single follow-up workflow for chronic disease management. It includes protocol-based configurable clinical alerts, enabling care teams to prioritise patients who need intervention, as well as secure messaging and video consultation embedded in the clinical workflow through electronic health record integration.

The platform connects bidirectionally with hospital EHR/EMR systems through interoperable APIs based on FHIR and HL7 standards (among others), and offers specialty-specific care pathways for cardiology, respiratory disease and other conditions.

Among the functionalities assessed is AI-powered smart image scanning, which automatically captures and interprets medical device readings from a photograph, reducing data-entry errors and speeding up patient follow-up.

AI assessed under the MDR and aligned with the EU AI Act

A distinguishing feature of this certification is that the scope audited by the notified body expressly includes the artificial intelligence components, which are subject to the same risk management, verification and validation requirements as the rest of the medical device software.

The company has also developed its AI strategy in line with the European Artificial Intelligence Act (EU AI Act), progressively embedding its principles — transparency, human oversight and data governance — into its quality management system, ahead of the regulation's full application to high-risk AI systems.

The MDR certification adds to vitalera's existing security and compliance credentials: ISO 27001, Spain's National Security Framework (ENS) at High level, GDPR compliance and HIPAA alignment.

In the company's words

Unai Sánchez Luque, CTO and co-founder, underlines the technical complexity of the process: "Certifying a multimodal AI- platform under the MDR is far more complex than certifying an isolated feature. We put the entire software lifecycle through audit — including cybersecurity, infrastructure and artificial intelligence — and we come out of it stronger, both as a product and as a team."

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