Can a medical software qualified as class III?



Hello all,

We have a software which is used by the cardiologists for planning the implanting of stents. The stents are classified as class III according to the rule 8 of Annex IX MDD. "devices to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class III"

Therefore I assume that the article 2.3 in Annex IX "Software that controls or effect the use of a product should automatically have the same class as the product" should be implemented, and the software should be qualified as class III.

However, from the MEDDEV 2.1/6 I read something like:

"Stand alone software that meets the definition of a medical device shall be considered as an active medical device. This means that rules 9, 10, 11 and 12 of Annex IX to Directive 93/42/EEC may apply."

This is where the questions arise, for the classification of active medical devices, the highest level is IIb. This makes a SW with class III not convincing. So my questions are:
1. Since the surgery plan it generated should be applied with the specific stent, is the SW a stand-alone SW?
2. Which article should be implemented for the classification?


Quite Involved in Discussions
That's an important questiion, I would go through with my notified body to be honest.

The question you have is to determine what is the intended use of your software and what is the use environment. Further to assess the safety extent of your device and than I think you will have a good impression to its classification.

I would stick with to talk to the notified body, you should talk to anyway, it saves some headache.

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