The Awario service by Heart2Save is a registered Class IIa medical device and complies with all the regulatory requirements set for a medical device. It is approved by a Notified Body in accordance with the Council Directive 93/42/EEC. With the help of the service, you will be able to monitor your heart and heart arrhythmia can be diagnosed.
Medical device
The Awario service is designed to diagnose arrhythmias and monitor heart rhythm. As a CE marked medical device, it provides reliable and appropriate information.
What is a medical device?
The Medical Device Directive (Council Directive 93/42/EEC) will be replaced by the Medical Device Regulation 2017/745/EU after the transition period in May 2021.
According to the EU Medical Device Regulation 2017/745 a ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
Devices for the control or support of conception
Products specifically intended for the cleaning, disinfection or sterilization of devices
The journey of a medical device
Before a medical device can be legally marketed and sold in the European Union, CE marking is needed. The CE certificate verifies that the device meets all regulatory requirements for medical devices. A medical device’s safety, suitability for intended use and performance must be established before a CE marking can be affixed to the device to indicate conformity with the requirements.
Medical devices deemed to be high-risk, such as Awario, are obliged to have a CE certificate by a Notified Body to prove the fulfillment of requirements. Years of research and clinical validation are needed before the device can be audited and certified.
A Notified Body supervises changes made to the device until the end of its life cycle. If the manufacturer makes changes to the medical device, the Notified Body should be informed. Adverse incidents should always be reported to the Notified Body as well as to the Finnish Medicines Agency Fimea.