Who is the Manufacturer - Medical Device Accessories?

M

medgar

#1
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?
 
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yodon

Staff member
Super Moderator
#2
Not completely comfortable wading into these waters but the post has languished long enough. Maybe this will stimulate more discussion.

Manufacturers that have electronics boards didn't manufacture the resistors and other components, they are merely commercially acquired items going into the assembly. The system will need to comply with the MDD. In your case, I would presume you would take the system through product safety testing (60601) and that would likely be sufficient to show compliance.

I wouldn't think any additional labeling would be included other than installation instructions.

Keep focused on the system and how the components are integrated into the system.
 

Mark Meer

Trusted Information Resource
#4
You might have to be careful given that the device is medical-electrical, and so, presumably, you are going to test to IEC 60601-1 & 60601-1-2?

If this is the case, likely your test lab (again, presuming you go through one), will probably be checking the keyboard & mouse and their connections to the computer and device...

Therefore, you might need to include a precaution in the labelling to the effect of "use only with supplied keyboard and mouse".

Practically speaking, given the ubiquity of interchangeable keyboards and mice, it shouldn't matter. ...but from the test lab's perspective, they will back their safety testing only if no components are substituted...
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Therefore, you might need to include a precaution in the labelling to the effect of "use only with supplied keyboard and mouse".

Practically speaking, given the ubiquity of interchangeable keyboards and mice, it shouldn't matter. ...but from the test lab's perspective, they will back their safety testing only if no components are substituted...
This can and should be covered in the risk management file.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
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?
Hi,

The keyboard and mouse are not Accessories in the formal sense, because (presumably) their manufacturer didn't designate them to be used specifically with the subject medical device. Rather, they're simply components of the finished device. The finished device manufacturer does not become "the keyboard and mouse manufacturer" just because it uses them, but it does become responsible for the overall performance of *its* device, which includes the KB and mouse as components. The finished device needs to comply with the MDD (assuming distribution in the EC). The KB and mouse don't - as stand-alone items - as long as they are placed on the EC market as integral components of the finished device.

Cheers,
Ronen.
 
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