Medical Device Software in the MDR

In October 2019, the Medical Device Coordination Group (MDCG) issued a document to assist manufacturers of medical device software.
Radiological image viewers for diagnostic purposes, electronic health records with various associated functions, EMG signal analyzers, ECG trace viewers, systems to stimulate movement execution in rehabilitation, etc.

In short, browsing through the list of medical devices notified in the Database, the world of software with medical intended use seems endless.
The hope of understanding, thanks to the guideline, the application of the classification rule 11 for stand-alone software in the MDR, quickly fades by page 13.

The words “intended to provide information used to make decisions for diagnostic or therapeutic purposes” describe, in very general terms, the “mode of action” which is a characteristic of all medical device software. Therefore, this rule is generally applicable to all medical device software.

And it goes on to say that such software falls, at least, into class IIa, forcing manufacturers to manage a change in class for their software that was previously in class I.

Did the person who wrote “provide information used to make decisions for diagnostic or therapeutic purposes” really have all software in mind? Why then wasn’t it simply written “medical device software falls into class IIa or higher”?

Perhaps time and practice will bring about a different interpretation. Not today. Although there is a positive aspect.

The guideline clearly shows that defining a product as a “medical device” cannot be based on commercial needs. Instead, there must be an actual need to subject it to stringent controls aimed at ensuring patient safety.
Always hoping that those who draft tenders understand the need to consistently revise participation requirements.