The Regulation 2017/745 (MDR) introduced several news for software classified as Medical Devices (Medical Device Software, MDSW).Classification Rule 11 and the Medical Device Classification Guidelines (MDCG) 2019-11 and 2021-24 need to be taken into consideration for the proper classification and management of the MDSW.
Which kind of software can be classified as a medical device?
As reported in MDCG guidelines 2019-11, software must have a medical purpose on its own to be qualified as a medical device software. For example, a software which directly controls a medical device (hardware), provides immediate decision-triggering information, provides support for healthcare professionals or is intended to process, analyze, create or modify medical information altering the representation of data, can be classified as MDSW.
On the other side, a software used for “simple search” function (e.g. library functions), which alters the representation of data for embellishment/cosmetic or compatibility purposes or used for task such as e-mailing cannot be classified as MDSW.
Once verified that the software can be classified as a medical device, classification Rule 11 of MDR must be applied also considering the requirements of MDCG 2021-24 as follows:
- Class III: software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, only if these decisions can lead, as a consequence, to “death or an irreversible deterioration of health conditions“ (e.g. software for recognizing the shockable rhythm).
- Class IIb: software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, or to monitor vital physiological parameters, only if these decisions can lead, as a consequence, “a serious deterioration of a person’s state of health or a surgical intervention” (e.g. software for breath monitoring in unconscious patients).
- Class IIa: software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, or to monitor vital physiological parameters, only if these decisions cannot lead, as a consequence, to “death or an irreversible deterioration of health conditions” or “a serious deterioration of a person’s state of health or a surgical intervention” (e.g. software for monitoring the sleep-wake cycle).
- Class I: any other software (e.g. software for monitoring the perceived quality of life of patients undergoing physiotherapy).
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