Is Software a medical device? A classification rationale
Software is becoming more and more important and essential in our current Healthcare Scenario. Its significance has grown in multitudes from integral part of medical devices to standalone software to mobile applications. The first step for a manufacturer is to qualify whether the software falls into the category of Software as a medical device (SaMD). The MEDDEV standards can be utilized to understand if it in itself is a medical device. If the software is an accessory to the Medical Device it is not covered separately but included as a component of the device itself.
The analysis of whether or not the Software falls into the medical device category can be determined with the following criteria if the Software is intended for analysis of Patient data with a purpose of Diagnosis and Monitoring, If the software is intended for use by patients to diagnose or treat ailments, If it is a component or part of a medical device.
There are several categories of Medical Device Software such as: Image processing software, Picture Archiving and communications Software (PACS), Standalone software used to collect information from Implantable devices, Standalone software used to collect information from clinicians to analyze data, Radiation Therapy Software, Apps for mobile Phones.
The function of the software determines its classification based on the MEDDEV guidelines for CE marking. If the software is a medical device it can be classified as class 1 but if it is an integral part of a class III device then it will be a class III software.
The software Lifecycle process is dealt with in the IEC 62304 standard covering both standalone as well as component Software. This standard lays importance to the quality and risk management during the development of Software. The risk classification as laid down by this standard are class A, B, C where C being the highest risk.
Thus the focus of the manufacturers should be on the delivery of safe Software for use on patients. For further information and expert advice and knowledge author recommends you to contact I 3 Consulting.
Jeyadevi Rajesh is a Regulatory Specialist at I 3 Consulting, a leading consultant firm specializing in CE and FDA submissions.