Medical Device Service Records linked to DHR (Design History Record)?

Aphel

Involved In Discussions
#1
Hello,

Actually I have to cope with discussions regarding service records (?820.200).
Are service reports part of the DHR (?820.184)?

When I am considering the following requirements (red):

?820.181 states:

The DMR for each type of device shall include, or refer to the location of, the following information:
[...]
(e) Installation, maintenance, and servicing procedures and methods.


?820.184 states:

Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part.

The DHR shall include, or refer to the location of, the following information:
[...]
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
[...]

- then I come to the conclusion, that service records are part of the DHR, because they demonstrate conformance with service procedures...

Are my guesses correct?

Thank you very much for your support!

Best regards,
Aphel
 
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#2
Re: Device service records linked to DHR?

FDA makes clear that servicing procedures are part of the DMR, but my view is that they don't make clear how to handle individual-unit service records.

My view is that service records are an independent mandatory record-type, alongside the DHR, DMR and DHF. In practice, we treat them the same as DHR records.
 
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