The European Commission’s Medical Device Coordination Group (MDCG) have unveiled a guidance on qualification and classification of medical software under the new European Union’s (EU) Medical Devices Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR).
Medical device software (MDSW) is defined as software intended for medical purposes as specified in the MDR and IVDR, regardless of whether it is independent or influencing another device. This guidance outlines the criteria for qualification of software as an MDSW and classification under MDR or IVDR, and is aimed at medical software manufacturers.
The guidance discusses various types of software that can qualify as MDSW. For example, software which uses transrectal ultrasound findings, age and in-vitro diagnostic instruments to calculate a patient’s risk of developing prostate cancer, qualifies as an independent MDSW. Melanoma image analysis software intended to drive near-infrared laser light scanners qualifies as MDSW capable of “driving or influencing” a hardware medical device. These guidelines also apply to applications (apps) being operated from a mobile phone, cloud or alternative platform, and those intended for use by laypersons, for example, an MDSW that provides insulin dose recommendations to a patient regardless of the method of delivery.
The guidance also details a step-by-step guide and includes separate decision trees for the qualification of MDSW as either medical or in-vitro. It then describes rules for classifying MDSW and how they can be implemented, based on the “significance of the information provided by the active device to the healthcare decision (patient management) in combination with the healthcare situation (patient condition)” and the risk associated with the device. Further sections include marketing considerations and conformity assessments, as well as considerations of changes to an MDSW which can lead to a revision of its qualification or classification.
Manufacturers must ensure that all regulatory requirements have been fulfilled. Any claims relating to the intended medical purpose of their MDSW must be supported by clinical evidence. Failure to do so would mean the software would not meet the requirements of the regulations and therefore may not be “CE-marked” as a medical device.
To view the full guidance, click here.