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The final version of the Guidelines on the Qualification and Classification of standalone software used in healthcare within the regulatory framework of medical devices has been finally published (earlier than expected)
The document can be downloaded here (.pdf)
I think it is a good guideline. It will be of help to reduce the big confusion which was triggered two years ago by people without sufficient experience in this topic.
And the most important content is the clarification, that the decision is always up to the legal manufacturer.
The document can be downloaded here (.pdf)
I think it is a good guideline. It will be of help to reduce the big confusion which was triggered two years ago by people without sufficient experience in this topic.
And the most important content is the clarification, that the decision is always up to the legal manufacturer.