What is a medical device?
The AiVoni® -service developed by Heart2Save is in its final phase of medical device approval (Class IIa). With the help of the service, you can monitor your heart and diagnose heart arrhythmia.
The AiVoni® -service consists of the following components:
The AiVoni® -measuring device (electrodes + sensor)
The AiVoni® for Android -application
The AiVoni® -analyses service
According to the Council Directive 93/42/EEC a ‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the
manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- supporting or sustaining life,
- control of conception,
- disinfection of medical devices
- providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.”
- Based on the ECG provided by the AiVoni® -service health care professionals can reliably diagnose the arrhythmia and begin the treatment best suited for the patient.
Before a medical device can be legally marketed (sold) in the European Union, a CE Mark certificate is needed. This certification verifies that the device meets all regulatory requirements for medical devices.
Years of research and clinical validation is needed before the device can be audited and certified. Finland has a few Notified Bodies, conformity assessment bodies, that have been designated to carry out conformity assessment according to EU regulations, and that can issue certificates. If changes are made to the device, the Notified Bodies and Valvira should always be informed.