The Commission issued an updated version of the MEDDEV 2.1/6 regarding standalone software on 15 July. After all the rumors around the difficult discussions surrounding the revision process I was very curious about the changes finally implemented.
Unfortunately these changes turned out to be very limited and in my view do not change the scope of the document or even bring anything new. Essentially what happened is that the Commission added some definitions and slightly amended the flow chart for qualification under the Medical Devices Directive by amending the first decision node of the flow chart.
Definitions and flow chart
The definition of software has been changed to a “set of instructions that processes input data and creates output data“. The new definition of software is used in the new question in decision node 1 in the Medical Devices Directive flow chart (“Is the product a software?”).
The MEDDEV defines the concepts of input data (“any data provided to software in order to obtain output data after computation of this data“) and output data (“any data produced by a software“) embedded in the new definition of software. The MEDDEV provides for a non-exhaustive list of examples of input data (data given through human interface input devices, documents and data received from / transmitted by devices) and output data (e.g. screen, print or audio data; digital documents). Nothing really surprising.
The MEDDEV now includes the definition of “Software as a Medical Device” (SaMD) from the IMDRF work item on software, but the definition is not operationalized anywhere in the MEDDEV, because the document only refers to the separately defined term “software”. The definition has no apparent function in the MEDDEV other than seemingly paying tribute to the IMDRF work on software.
The new MEDDEV version contain a new statement to the effect that “The criteria specified in this document apply also to mobile applications.”. Again, not surprising because we knew that already since mobile apps were always software in scope of the MEDDEV. It’s a pity though that the revised MEDDEV does not contain any actual guidance specifically for mobile apps. That means we’re left with the guidance on mobile apps in the Manual on Borderline and Classification, which looks to be further expanded on ad hoc basis as the Manual evolves.
Is this progress? Well, somewhat. However, to me it’s disappointing that the EU does not have more additional guidance to account for after four and a half years of experience with the software MEDDEV. It shows that the expert group working on the MEDDEV had a very difficult job in coming to agreement on what to put into the revised version because there are more than enough questions that could have been addressed. A missed opportunity, given the importance of the subject.