Certification as a Class IIb MD according to Regulation (EU) 2017/745
The MDR establishes the rules applicable to the placing on the market, making available on the market and putting into service of medical devices and respective accessories within the Union. This Regulation aims to establish a robust and transparent regulatory framework in order to guarantee the technological and clinical safety and effectiveness of medical devices.
The classification of medical devices by risk class (I, IIa, IIb and III) is carried out in accordance with Annex VIII of the MDR. Rule 11 establishes specific criteria for the classification of software:
The software that controls the device or influences its use is classified within the same risk class as that device, but if it is independent of the device, it is classified alone.
Software For Therapeutic Decisions or Diagnosis: the software devised to supply information used to take decisions with therapeutic or diagnostic purposes is generally classified as class IIa.
High Risk Software: the classification increases if the decisions supported by the software may have serious consequences.
1. The software is classified as class III if the decisions it supports may cause death or an irreversible deterioration of a person’s state of health.
2. The software is classified as class IIb if the decisions it supports may lead to the serious deterioration of a person’s state of health or the requirement for a surgical intervention.
Physiological Monitoring Software: the software for monitoring physiological processes is classified as class IIa. However, if it is intended for monitoring vital physiological parameters where the variation of such parameters may result in immediate danger to the patient, it is classified as class IIb.
Low Risk Software: any other software that does not fall within the criteria of high risk is classified as class I.
Classification as a class IIb medical device was obtained in October 2023, reinforcing HCAlert’s ability to monitor vital physiological parameters where the variation of those parameters may result in immediate danger to the patient. This aspect enables the healthcare professionals to intervene and make a clinical decision within the context of intervention when the patient is in immediate danger.
Certification as a medical device was obtained through the intervention of the Notified Body TUV Rheinland (0197), which carried out the conformity assessment activities in order to guarantee the protection, safety and clinical validation of HCAlert.
HCAlert is registered under:
