Class 1 Medical Device

The Italian Ministry of Health awarded COVID Feel Good the certification of Class 1 (EU Reg. 2017/745) Medical Device 

Name: "Augmented Well-Being"       Code: 2436695

In October 2019, the European Commission’s Medical Devices Coordination Group (MDCG) published a new guidance on the qualification and classification of software as medical devices (MDSW) under the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) (the “Guidance”). The Guidance aims at providing clarification to medical software manufacturers with respect to (i) qualification issues (when software is considered a device); and (ii) classification issues, depending on the risk category of the device.

As to qualifying software as a medical device, there are no significant changes compared to the current regulatory framework. Conversely, with respect to the classification issues, the Guidance generally assigns to MDSW a higher class of risk compared to the current one, under Rule 11 of the MDR, as better explained below.

The Guidance also specifies that the criteria reported therein shall also apply to applications (apps), whether they are on a mobile phone, in a cloud or on other platforms.

1. Software as medical devices under the MDR

According to the new classification rules provided by the MDR (Rule 11):

1. Software intended to provide information used to take decisions with diagnosis or therapeutic purposes is classified as Class IIa, except where such decisions have an impact that may cause:

   • death or an irreversible deterioration of a person’s state of health, in which case it is in Class III; or

   • a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as Class IIb.

2. Software intended to monitor physiological processes is classified as Class IIa, but

   • if it is intended to monitor vital physiological parameters, where the nature of variations of those parameters is such that could result in immediate danger to the patient, it is classified as Class IIb.

3. All other software is classified as Class I.