Here is some follow up on the previous Blue Guide post: the new version of the Blue Guide is the first to address software updates to CE marked products, including software. For the purpose of this blog this would typically be standalone software that constitutes a medical device in the meaning of MEDDEV 2.1/6.
Harmonised standards
When standalone software that constitutes a medical device is updated, patched or has its functionality expanded with a plug-in or add-on, the same rules apply as to a normal me [...]
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