Health care
Medical device
Heart2Save’s Awario® service is
a registered Class IIa medical device.
With the help of the service you can
diagnose heart arrhythmias and
follow your heart rhythm.
Awario® service consists of following components:
Awario Care measuring device
Awario Application
Awario Analysis Service
What is a medical device?
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.
The journey of a medical device
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 Fimea (Finnish Medicines Agency) should always be informed. More information on Fimea’s homepage.
