Signals
Actimi Signals is standalone, cloud-based medical-device software. It analyzes clinical data, evaluates patient-specific rules, and returns alert decisions to compatible software through an API.
When a product uses Signals, Ovok stores connected-device data as FHIR resources and sends all of that product's vital-sign data to Signals for evaluation. Signals returns decisions through its API, and Ovok makes those decisions available to your application. Signals is MDR Class IIa; Ovok is not a certified medical-device product.
Is Signals required?
No. If you are building a non-clinical product that does not need medical alert evaluation, you can opt out of Signals. You can still use Ovok's FHIR APIs without using Signals.
Product details
| Detail | Information |
|---|---|
| UDI-DI | 42700031203-API-XG |
| Security contact | security@actimi.com |
What Signals does
Signals can analyze clinical data captured by compatible medical devices or supplied by other software through its API. Based on that data, it can:
- generate patient-specific alerts;
- create prioritized patient lists using preconfigured rules and validated algorithms informed by international clinical-society recommendations; and
- support regular data collection, monitoring, and trend reporting, including rules configured for an individual patient by a medical practitioner.
Signals is not intended to present results directly to end users. It returns results through an API to compatible software, which can process them and provide the interface clinicians use. In an Ovok-powered product, use Ovok APIs to bring the resulting decisions into your application's care workflow.
How Signals fits with Ovok
- Compatible devices or connected software provide clinical measurements.
- When Signals is enabled, Ovok stores the clinical data as FHIR resources and sends all vital-sign data for alert evaluation.
- Signals evaluates the data and returns its decisions through an API.
- Ovok surfaces those decisions to your application, where your product implements the clinician-facing workflow. If you opt out of Signals, this alert-evaluation flow does not apply.
Your application remains responsible for its own experience and workflow. Signals provides the analysis service; Ovok provides the FHIR data layer and API used by your application.
What MDR Class IIa means
Class IIa is one of the medical-device risk classes defined by the EU Medical Device Regulation (MDR). The MDR's Annex VIII sets out classification rules based on a device's intended purpose and risk. Rule 11 addresses software that provides information used for diagnostic or therapeutic decisions and software intended to monitor physiological processes; it also sets out circumstances that can result in a higher class. See the MDR, Annex VIII, Rule 11 and the European Commission's software qualification and classification guidance, MDCG 2019-11 rev.1.
Actimi Signals' Class IIa status applies to Signals as a medical-device software product. It does not certify Ovok or automatically give the same status to an application that integrates with Signals. Ovok is a backend platform, not a certified medical device.
What this means for your app
Showing a Signals alert does not, by itself, decide whether your app is a medical device. The MDR assessment is based on the app's own intended purpose and what it is designed and presented to do. The intended purpose is informed by the manufacturer's statements in product materials, instructions for use, promotional or sales content, and clinical evaluation—not just by a disclaimer or the fact that the app uses a certified service.
The boundary depends on the complete workflow. Software limited to storing, transferring, or simply displaying information may be treated differently from software intended to interpret or prioritize patient data, monitor a condition, recommend an intervention, or provide information used for diagnosis or treatment. A user interface can still be part of medical-device software when its intended purpose is to support clinical decisions. There is no blanket exemption for an app described as “display only.”
For an Ovok-powered app, assess these points together:
- Purpose: What medical purpose, if any, do you claim for the app, and who is it intended to help—clinicians, patients, or both?
- Role of the alert: Does the app pass through the Signals result, or does it add interpretation, ranking, recommendations, escalation logic, or actions that influence care?
- Use in care: Is the information intended to support diagnosis or treatment decisions, or to monitor a physiological process? What does the user understand they should do with an alert?
- Product claims: Do the app's name, interface, documentation, instructions, and marketing describe a clinical function, even if the code only displays a result produced elsewhere?
If your app has a medical intended purpose, assess it as its own software product under the MDR. Rule 11 may apply when software provides information used for diagnostic or therapeutic decisions, or is intended to monitor physiological processes. The resulting class depends on the intended purpose and the Rule 11 criteria; Signals' Class IIa classification does not set your app's class. The same assessment applies whether the software runs on a phone, server, or in the cloud.
A practical review before release
- Write down the app's intended purpose, intended users, and the role of Signals results in the care workflow.
- Compare that statement with the app's actual behavior and all user-facing claims, including alert labels, prioritization, notifications, and recommended next steps.
- Document your qualification and, if applicable, classification rationale against MDR Annex VIII Rule 11 and the European Commission's software guidance.
- Get a product-specific assessment from a qualified EU medical-device regulatory professional before placing the app on the market. Do not infer the answer from Ovok's status, Signals' class, or a UI disclaimer alone.
This is a practical summary of public EU guidance, not a legal determination for your product. See the MDR definition of intended purpose and medical device and the European Commission's MDCG 2019-11 rev.1 software qualification and classification guidance.
Official intended purpose
Actimi Signals is a medical device stand alone cloud-based software intended to analyze clinical data captured by compatible medical devices or supplied by other software via the API. Based on the input, Actimi Signals generates patient-specific alerts and creates prioritized lists of patients based on pre-configured rules, using several validated algorithms, based on the recommendations of international societies, or based on a patient-specific rules set by an individual medical practitioner for a specific patient. Therefore, Actimi signals can bring to the clinician's attention those monitored patients potentially in need of clinical intervention or can be used for regular data collection, monitoring and trends reporting. Actimi Signals is not intended to directly present the output to the user, instead, it communicates the results via API and supplies them to a compatible software (i.e. software using adequate API), which can further process the data or provide a graphic user interface to a user.