Service manuals are generally considered to be part of the device "labeling", specifically part of the instructions for use. Consequently, we need to "treat" them accordingly (e.g., as controlled design outputs, labeling, Device Master Record / Medical Device File elements; etc.). This requirement is established by U.S. medical device law (e.g., via the statutory definition of "labeling") and likewise by other authorities like the IMDRF, EN ISO 20417, EN ISO 13485, etc.
To give definitive direction about the consumables question, we need more details (description, specific intended use, etc.) about the consumables that you state are used only for checks to ensure the system meets the required calibration. For example, if such consumables are controls or calibrators needed by users and are replenished in ongoing fashion for the device to continue functioning as intended, then such consumables can ultimately be considered to be part of the finished device and thus need to be identified, labeled, traced, etc., accordingly. On the other hand, if the consumables are just general laboratory items, then that helps get them apart from finished medical device or device component regulatory control.
Europe's Union MDR requires the CE mark to appear in any instructions for use. Consequently, the CE mark needs to appear on the service manual and operations manual since the Union MDR (and EN ISO 20417, EN ISO 13485, IMDRF etc.) considers these to be part of instructions for use.
21 CFR Part 801 generally governs requirements for the label on a finished device rather than on a device component (e.g., raw material, piece, part, etc., such as a replacement part). But if a replacement part is sold/marketed/distributed separately for a particular medical intended use (e.g., such as for user DIY replacement of worn parts on medical devices), then the Part 801 label requirements would take effect for such item. Yet if such replacement part is not being sold/marketed/distributed for such an end use but rather arrives for example by way of, or on behalf of, a manufacturer's own (or contracted) service technician who does the field servicing, then the labeling requirements for such part are governed by 21 CFR 820.60 Identification rather than Part 801.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 13-Mar-2024 23:24
From: Anne LeBlanc
Subject: Service instruction labeling for servicable parts
Hello Anon
Spare parts do need to be appropriately labeled. They are usually not medical devices in themselves, in which case they must not be labeled as medical devices. The CE marking only goes onto things that meet the requirements of one of the CE-marking regulations or directives, which spare parts most often do not.
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Anne LeBlanc
United States
Original Message:
Sent: 08-Mar-2024 16:59
From: Anonymous Member
Subject: Service instruction labeling for servicable parts
This message was posted by a user wishing to remain anonymous
Hello,
I would like to know how do we treat service manuals that are used by field personnels?
Some consumables are used only for checks to ensure the system meets the required calibration.
For EU, do we usually CE mark this operations manual and the product?
Is there a need to follow the requirements for all the labeling laid out under 21 CFR 801 for servicable parts?
Do we genrally treat these as a part of our regular labeling approval process or can we be more lenient with these?
Thanks,