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.