We produce a standalone software considered as a Class I medical device under this MDR. During our last HC inspection, the inspector told us that all field software upgrades should be considered a ‘recall’ based on point ‘b’ of the definition which reads as follows:
“(b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety;”
Like any software product, we occasionally have field upgrades to improve functionality or slight anomalies detected over time. However, being a Class I device, these do not pose any risks to users. We therefore find it to be an extreme interpretation that any field upgrades have to be reported per the Recall requirements (sections 63-65).
I’m hoping to get feedback regarding interpretation of the Recall definition and requirements in the context of software upgrades.
Note that I browsed through several threads in the ‘Canada Medical Device Regulations’ forum already and couldn’t find anything about Recall. If there is such a thread I’d appreciate a link to it.
Thanks in advance.
“(b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety;”
Like any software product, we occasionally have field upgrades to improve functionality or slight anomalies detected over time. However, being a Class I device, these do not pose any risks to users. We therefore find it to be an extreme interpretation that any field upgrades have to be reported per the Recall requirements (sections 63-65).
I’m hoping to get feedback regarding interpretation of the Recall definition and requirements in the context of software upgrades.
Note that I browsed through several threads in the ‘Canada Medical Device Regulations’ forum already and couldn’t find anything about Recall. If there is such a thread I’d appreciate a link to it.
Thanks in advance.