Which class I accessory information should be kept in the Technical File

[shimonv]

Hi fellows,
Say you have a class I make item accessory with its own design input/output files. Will you include the detailed accessories information (requirements, V&V, labeling, etc.) in the technical file or just a brief description in the Technical Files and complete details in a separate DHF record?

I believe the second option is correct, but would appreciate hearing what is your experience with NBs.


Thanks,
Shimon

 

[rob73]

We have a separate DHF for accessories, with a document in the main product DFH listing accessories that can be used with the main product and the location of the DHF for that accessory.

 

[shimonv]

Thanks Rob, good input.
So following this line of thought - do you have two technical files, one for the device with a brief description of the accessories and one for the accessories?

Thanks,
Shimon

 

[Ronen E]

In the EU accessories are treated as devices, so every accessory should have its own Technical File.

 

[rob73]

Shimon
Yes, as Ronen points out each devices has to have its own DHF, even accessories. That's not to say you cannot group them if their intended use and design are the same. For instance we manufacture a range of disposables. They vary in size and port configuration but are basically the same device. These are grouped as a product family, the DHF for these references the accessories and their DHF.

 

[shimonv]

Thanks Rob and Ronen,
I am adding input from another colleague of mind which should wrap it up:

"If the accessory has its own CE Mark based on its own intended use, then it would have its own technical file since it's a class 1 self-declare.
If the accessory is part of the medical device system/family that is being CE Marked and dependent on the bigger system's intended use, then I would include the information in the bigger technical file."


Best,
Shimon

 

[Ronen E]

If the accessory is part of the medical device system/family that is being CE Marked and dependent on the bigger system's intended use

In that case it might be an accessory in the everyday English meaning but it wouldn't qualify as an Accessory as defined by the MDD.

I was assuming all along we are discussing an Accessory in the MDD meaning.