The European Commission has issued a new flowchart to clarify when software will qualify as a medical device.
The flowchart does provide a helpful breakdown of some elements of the decision process. However, it might benefit from a couple of changes (at which time, perhaps the typographical errors could be corrected). Oddly, the flowchart makes limited mention of the concept of medical purpose – normally the key factor when considering whether software is a medical device.
In the first flowchart, Point 2 is problematic. It brings the question of whether software might be an accessory to the forefront of the decision process when one might expect this to be the final question. More importantly, there is no clear link between Point 2 and Point 3, leading to the – manifestly incorrect – possibility of concluding that if Software is neither an accessory nor an Annex XVI product, it is not a medical device.
As an aside, Point 2 also refers to Annex XVI products – that is, products such as cosmetic contact lenses and dermal fillers which have no medical purpose. As far as we are aware, it is impossible for any Annex XVI devices to be software.
We applaud the effort to clarify a challenging space, but would encourage the Commission to consider a corrigendum.