M
medgar
I am having some difficulties with the definition of 'manufacturer' as it applies to accessories to a med dev.
Scenario: a med dev has as 'integral' accessories a mouse, keyboard etc. That is, the med dev cannot be operated without these items.
The 'intended purpose' of the the keyboard and mouse have not changed from their intended purpose by their actual manufacturer (for use with a computer). The labelling and packaging of the keyboard and mouse are included within the outer packaging for the med dev as are their IFUs?
Does the med dev manufacturer become the 'manufacturer' of the keyboard and mouse? Does the keyboard and mouse need to comply with the MDD?
Scenario: a med dev has as 'integral' accessories a mouse, keyboard etc. That is, the med dev cannot be operated without these items.
The 'intended purpose' of the the keyboard and mouse have not changed from their intended purpose by their actual manufacturer (for use with a computer). The labelling and packaging of the keyboard and mouse are included within the outer packaging for the med dev as are their IFUs?
Does the med dev manufacturer become the 'manufacturer' of the keyboard and mouse? Does the keyboard and mouse need to comply with the MDD?
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